[Federal Register: November 6, 1998 (Volume 63, Number 215)]
[Rules and Regulations]               
[Page 60121-60164]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no98-11]


[[Page 60121]]

_______________________________________________________________________

Part IV





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



21 CFR Part 26



Mutual Recognition of Pharmaceutical Good Manufacturing Practice 
Inspection Reports, Medical Device Quality System Audit Reports, and 
Certain Medical Device Product Evaluation Reports Between the United 
States and the European Community; Final Rule

Memorandum of Understanding Between the Food and Drug Administration 
and the Office of the United States Trade Representative; Notice


[[Page 60122]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 26

[Docket No. 98N-0185]
RIN 0910-ZA11

 
Mutual Recognition of Pharmaceutical Good Manufacturing Practice 
Inspection Reports, Medical Device Quality System Audit Reports, and 
Certain Medical Device Product Evaluation Reports Between the United 
States and the European Community

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations pursuant to an international agreement between the United 
States and the European Community (EC). The agreement is entitled 
``Agreement on Mutual Recognition Between the United States of America 
and the European Community'' (MRA). Under the terms of that agreement, 
the importing country authority may normally endorse good manufacturing 
practice (GMP) inspection reports for pharmaceuticals provided by the 
exporting authority determined by the importing authority to have an 
equivalent regulatory system. Likewise, the importing country authority 
may normally endorse medical device quality system evaluation reports 
and certain medical device product evaluation reports provided by 
conformity assessment bodies (CAB's) determined by the importing 
country authority to have equivalent assessment procedures. FDA is 
taking this action to enhance its ability to ensure the safety and 
effectiveness of pharmaceuticals and medical devices through more 
efficient and effective utilization of its regulatory resources. The 
proposed rule which published in the Federal Register on April 10, 1998 
(63 FR 17744), carried an incorrect docket number in its heading. This 
final rule carries the correct docket number.

DATES: This regulation is effective on December 7, 1998. The Director 
of the Office of the Federal Register approves the incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a 
certain publication listed in new Sec. 26.60(b), effective December 7, 
1998. Written comments and information relevant to implementation of 
the MRA and this regulation may be submitted at anytime.

ADDRESSES: Submit written comments and information relevant to 
implementation of the MRA and this regulation to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Merton V. Smith, Office of 
International Affairs (HFG-1), Office of External Affairs, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
0910, or E-mail: ``MSmith@oc.fda.gov''.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 20, 1997, the United States and the EC concluded an 
agreement on the MRA. The MRA includes two sectoral annexes covering 
products regulated by FDA. The sectoral annex on medical devices covers 
medical device quality system-related inspection reports and certain 
product evaluation reports. The sectoral annex for pharmaceutical GMP's 
covers pharmaceutical GMP inspection reports. The MRA also includes 
sectoral annexes covering products regulated by other U.S. regulatory 
agencies, including telecommunication equipment, electromagnetic 
compatibility, electrical safety, and recreational craft. Finally, the 
MRA includes a ``framework'' agreement that contains general 
provisions.
    At the conclusion of negotiations, the United States and the EC 
submitted the text of the MRA to their respective authorities to 
complete the necessary procedures for approval and implementation. For 
FDA, these procedures included publishing a proposed rule that was 
published in the Federal Register of April 10, 1998 (63 FR 17744). The 
proposed rule was based on the provisions contained in the two FDA 
sectoral annexes and the ``framework'' agreement of the MRA concluded 
on June 20, 1997. FDA received comments from 14 persons in response to 
this proposed rule. Many of these comments supported the proposed rule. 
Some comments raised significant issues but none that, in FDA's view, 
necessitated any substantive changes to the proposed rule. On May 14, 
1998, FDA informed the Office of the U.S. Trade Representative (USTR) 
that it supported the signing of the MRA. The MRA was signed in London 
on May 18, 1998. Provisions of the MRA are between the United States 
and EC, and do not create rights in third parties.

II. Summary of Comments

A. General Comments and Issues

    Most comments by industry associations and pharmaceutical and 
medical device manufacturers generally were supportive of the MRA and 
the proposed rule. Some comments by others expressed concern about 
possible diminished public health and safety if certain precautions are 
not taken.
    1. Five comments strongly supported the MRA and the proposed rule, 
citing its potential to improve patient access to safe and effective 
technologies, reduce unnecessary regulatory redundancies, enhance the 
access of United States and EC companies to each other's markets, 
provide significant savings to both companies and regulators, and set 
the stage for further regulatory cooperation and harmonization. They 
indicated that the proposed rule and the MRA allow for incorporation of 
the best regulatory attributes.
    FDA agrees with these comments. FDA takes the view that equivalence 
of GMP reports and other conformity assessment reports and evaluations 
between the FDA and EC Member State authorities and CAB's can be relied 
on to help ensure the safety, quality, and effectiveness of products 
exported to the United States while also reducing the regulatory burden 
on manufacturers. For the United States, the MRA and this regulation 
also permit FDA to redirect some of its inspectional resources from 
countries whose systems are found equivalent to, or higher to, risk 
priorities not covered under the MRA. The agency may thus better target 
its limited foreign inspection and other resources devoted to imports 
and other regulatory concerns. Thus, FDA will be able to leverage its 
resources by relying on information from its counterpart regulatory 
authorities in foreign countries that have demonstrated equivalence. 
Under the MRA and this regulation, as equivalence is achieved between 
regulatory systems of EC Member State authorities, or CAB's, and FDA, 
there will be reduced need for importing countries to engage in 
resource-intensive foreign inspection, sampling, and examination of 
products being for entry from countries with equivalent systems. This 
can assist in speedier approvals of safe and effective products and in 
more comprehensive and effective surveillance of GMP's and quality 
systems. In addition, during the transition period, collaborative 
confidence-building activities between FDA and EC Member State 
authorities and CAB's can result in harmonization of requirements at a 
high level of

[[Page 60123]]

consumer protection, thus enhancing regulatory controls.
    2. One comment described three fundamental principles which 
underlie the comment's concerns about the MRA and the proposed rule: 
(1) The paramount goal for FDA implementation of the MRA and the 
proposed rule must be to safeguard public health of U.S. consumers; (2) 
equivalence determinations performed by FDA must improve or at least 
maintain current U.S. public health protections; and (3) the United 
States' democratically accountable, policy-making process must be 
maintained.
    FDA agrees with these comments. FDA has consistently articulated 
these same principles in its policies relating to international 
cooperative agreements over the last decade. In 1988, the FDA and 
Directorate-General III (Industrial Affairs) of the European Commission 
began early discussions in consideration of agreements in the areas of 
pharmaceutical and medical device GMP inspections. The FDA's primary 
motivation in seeking such agreements was at that time, and still is, a 
desire to leverage its limited inspectional resources and to enhance 
public health protection through increased assurance that regulatory 
counterparts are applying similar controls. FDA described the value of 
pursuing international cooperative agreements with selected foreign 
regulatory bodies in its 1992 ``Report of the Task Force on 
International Harmonization'' (Ref. 1). The Task Force concluded that 
such international agreements are an effective means of facilitating 
the safety, effectiveness, and/or quality of products that are offered 
for import into the United States and of efficiently setting priorities 
for the agency's inspectional resources. The Task Force concluded that 
a properly conceived and executed agreement would permit FDA's use of 
foreign government inspectional information to assist in the agency's 
regulatory decision-making and could help FDA to set priorities for 
foreign inspection or import surveillance programs. As a result of 
specific Task Force recommendations, in 1995 FDA revised its Compliance 
Policy Guide (Ref. 2) to emphasize that the agency's primary goals for 
entering into agreements with foreign governments are for the purposes 
of better utilizing its regulatory resources and furthering its mission 
of protecting the U.S. consumer.
    The significant increase of international commerce in 
pharmaceuticals and medical devices and the question of how FDA can 
continue to ensure the safety and effectiveness of these medical 
products prompted the agency to convene a Foreign Inspection Working 
Group in 1995 to evaluate the agency's foreign inspection program and 
related import product monitoring. In 1997, this group issued its 
``Summary Report of the Foreign Inspection Working Group'' (Ref. 3) 
that recognized the need for inspectional approaches that involve 
cooperative activities such as the development of international 
agreements between FDA and counterpart regulatory authorities in other 
countries.
    Section 26.21 of this rule provides that the importing country has 
the right to fulfill its legal responsibilities by taking actions 
necessary to ensure the protection of human and animal health at the 
level of protection it deems appropriate. In addition, under Sec. 26.74 
nothing in this part limits the authority of FDA to take appropriate 
and immediate measures that it determines necessary to prevent 
compromising human health and safety, or to fulfill its legislative, 
regulatory, or administrative responsibilities.
    To ensure a democratic and open process, the FDA will make 
available in a public docket the complete administrative file that 
constitutes the basis for FDA's equivalence determinations. In 
addition, any other related documents the agency receives under the MRA 
and this regulation will be releasable to the public (or not 
releasable) according to current Freedom of Information Act (FOIA) 
provisions. FDA also will assess the degree to which a foreign 
regulatory system or CAB is accountable to consumers and other 
interested parties as part of its equivalence determinations. (App. D 
of subpart A, criteria I.F.). A regulatory system that is not 
sufficiently transparent to assess accountability may not be found 
equivalent.
    3. One comment stated that the MRA and the proposed rule would 
replace FDA-conducted inspections of foreign pharmaceutical plants and 
FDA reviews of foreign medical devices with inspections and evaluations 
performed by EC Member State authorities and CAB's located in EC Member 
States.
    The implementation of the MRA and this regulation may or may not 
result in the replacement of some FDA inspections and product 
evaluations of medical devices produced by manufacturers located in EC 
Member States. Inspection reports and product evaluations may normally 
be endorsed under certain conditions only if, after a comprehensive 
assessment during the 3-year transition period, FDA determines that 
such reports will provide the information that FDA needs for its 
regulatory decision making.
    4. One comment stated that the MRA negotiation took place primarily 
for trade facilitation purposes. Evidence of this conclusion was 
offered by the fact that the negotiations were co-chaired by USTR and 
the Department of Commerce (DOC) and that press releases and other 
public statements have characterized the discussions as ``trade 
negotiations.''
    FDA participated in the negotiations leading to the MRA under its 
own authority to enter agreements with foreign authorities (see, inter 
alia, sections 519 and 803 of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 360(i), 383)). Furthermore, the agency believes 
that the MRA and this regulation, properly based on a rigorous 
determination of equivalence of regulatory systems, can help ensure the 
safety, quality, and effectiveness of these imports while also reducing 
the regulatory burden on manufacturers, thereby facilitating 
availability of these important medical products. The goals of 
facilitating trade and protection of the public health are not 
necessarily incompatible. The role of USTR and DOC was one of 
coordination. FDA's ability to reach decisions on the basis of its 
public health priorities was upheld, and never compromised, during the 
negotiations. FDA officials led the negotiations concerning the FDA 
annexes, and FDA's views were incorporated into the portions of the 
``framework'' agreement where FDA's interests were affected. USTR and 
DOC as well as European trade counterparts undoubtedly desired an MRA 
for trade reasons. Those agencies, however, supported FDA's position in 
the negotiations and did not interfere with FDA's desire to maintain 
health and safety protections. FDA believes that this degree of FDA 
autonomy will continue as the MRA and this regulation are implemented.
    Furthermore, FDA has entered into an interagency Memorandum of 
Understanding (MOU) with the USTR that ensures that any decisions about 
the MRA that relate to matters under FDA's jurisdiction will be made 
only by FDA (see the notice of availability for this MOU published 
elsewhere in this issue of the Federal Register). Specifically, the MOU 
requires that USTR notify FDA of matters that the Joint Committee will 
be considering. The MOU states that while USTR would normally speak and 
vote for the U.S. Government in the Joint Committee, subject to 
arrangements with other agencies covered by the MRA, FDA will speak 
for, and vote on behalf of, the U.S.

[[Page 60124]]

Government on any matter pertaining to FDA's statutory or regulatory 
authority raised within the Joint Committee or within any other bodies 
established under the MRA. In addition, the Sectoral Annex for 
Pharmaceutical GMP's is specifically exempted from certain provisions 
of the ``framework'' agreement, in order to avoid any possible 
confusion about the use of CAB's that are not utilized in the Annex. 
Finally, throughout the ``framework'' agreement and the FDA product-
related annexes there are clear safeguard requirements that stipulate 
if there are health and safety concerns on the part of the importing 
authority, the importing authority may take appropriate action.
    5. One comment stated that the goal of the MRA and the proposed 
rule appears to be to harmonize health, safety, and environmental 
standards to the lowest acceptable levels.
    While the process of confidence-building and equivalence 
determination may lead to harmonization of some standards, FDA 
disagrees that lowest common denominator standards will result. During 
the transition period, collaborative activities and joint equivalence 
determinations by FDA-EC Member State authorities and CAB's may result 
in harmonization of requirements that will enhance consumer protection. 
By law, section 803(c)(1) of the act requires the Commissioner of Food 
and Drugs (by delegation under 21 CFR 5.10) to work to ``harmonize 
regulatory requirements,'' but conditions these actions on findings by 
the Commissioner that ``such harmonization continues consumer 
protections consistent with the purposes of this Act.'' FDA's 
experience in working as a party to the Global Harmonization Task Force 
(GHTF), the International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use, and the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products has demonstrated that 
regulatory public health authorities do not compromise health and 
safety as standards are harmonized, because the relevant discussions 
and and the resulting documents have been thorough, science-based, and 
protective of public health. (Harmonization can lead to higher 
standards because in instances where one regulator has a requirement 
that others lack, the ensuing discussions of why one regulator has such 
a requirement often leads to understanding, acceptance, and inclusion 
of a corresponding provision in the harmonized standard.)
    6. One comment expressed the belief that the MRA and the proposed 
rule put U.S. consumer protection at risk of compromise and cited as 
evidence the fact that the negotiations extended well beyond their 
original deadlines, and were reportedly near collapse due to concerns 
about whether EC regulation is as stringent for pharmaceuticals and 
medical devices as U.S. regulation.
    The comment is correct in stating that the MRA negotiations took 
longer than expected and that FDA had concerns during the early stages 
of MRA discussions that early MRA drafts would not provide appropriate 
public health protections for U.S. consumers. For example, the 
provision for a 3-year confidence-building transition period was not 
considered during early MRA discussions. Acceptance of the need for a 
transition period during which time equivalence would be assessed was 
one of the keys to moving the MRA negotiations ahead. Indeed, Article 2 
of the Sectoral Annex for Pharmaceutical GMP's states that the 
determination of equivalence of the regulatory systems by the parties 
is the cornerstone of that Annex. FDA believes that the requirement of 
a comprehensive assessment of equivalence before inspection reports and 
product evaluations will be normally accepted, and other safeguard 
clauses such as Secs. 26.21 and 26.74, as discussed previously, provide 
strong public health protections. In the medical device provisions, EC 
acceptance that FDA must, as a matter of law and policy, maintain final 
decision making authority over premarket notifications, and that the 
MRA could cover premarket notifications only for certain devices, 
enabled conclusion of the MRA.
    7. One comment stated that FDA must make a commitment to seek 
additional resources to accomplish the activities required by the MRA 
and the proposed rule.
    In the preamble to the proposed rule, FDA acknowledged that neither 
startup costs nor operational costs are being covered by additional FDA 
funding in FDA's current budget and that startup costs will have to be 
absorbed by current funding. Certain key activities of the MRA and this 
regulation, such as joint inspections of manufacturers located in EC 
Member States, may be accomplished as part of FDA's inspections of 
these manufacturers that have been scheduled for the next fiscal year 
as part of FDA's normal budget process. Other activities of the MRA and 
this regulation will likely result in new costs. These additional costs 
are difficult to estimate because they depend significantly on the 
initial findings from FDA's equivalence assessments of EC Member State 
authorities and CAB's. FDA will likely be better able to estimate these 
additional costs as experience is gained during the first year of the 
transition period. After the first year, FDA will reassess its need to 
seek additional funding for the activities required by the MRA and this 
regulation.
    8. One comment stated that a failure to devote adequate resources 
to the programs of the MRA and the proposed rule during the 
implementation stage would endanger their success.
    FDA agrees with this comment. FDA will engage in activities during 
implementation as its resources permit. FDA recognizes the critical 
need to undertake a number of activities during the transition process 
as part of its assessment of the equivalence of CAB's located in EC 
Member States, including participating in seminars, workshops, joint 
training exercises, and observed inspections, as well as the analysis 
required for the equivalence determination process. In addition, any 
significant problem that is identified may require additional 
activities to address and resolve it. Finally, the parties will need to 
develop a consensus on what must be present in quality system and 
product evaluation reports (or, where harmonization cannot be achieved, 
each side will need to identify what it needs). Further, the parties 
will develop a notification and alert system for defects, recalls, and 
similar problems. All of these activities will require resources, and 
FDA recognizes their completion is critical to the success of the MRA 
and the implementation of this regulation.
    9. One comment stated that the number of repetitive inspections 
must actually decrease if the potential value of the MRA and the 
proposed rule is to be realized.
    FDA's interest in the MRA is its view that public health protection 
can be better assured through enhanced regulatory cooperation. Although 
FDA agrees that cost savings to industry and to government regulatory 
authorities can be realized by an actual decrease in the number of 
inspections that are unnecessarily duplicative, there are additional 
benefits that may be achieved by the activities required under the MRA 
and this regulation that make the MRA endeavor worthwhile. For example, 
the cooperative activities between FDA and EC Member State authorities 
that will of necessity be part of the equivalence determination

[[Page 60125]]

process may result in harmonization or congruence of requirements 
resulting in strengthened consumer protection, more effective 
regulatory approaches, and reduced regulatory burden on each side of 
the Atlantic.
    10. One comment suggested that FDA must use the inspectional 
savings anticipated by the MRA and the proposed rule for increased 
surveillance activities.
    Any resource savings resulting from the MRA and this regulation 
will be used by FDA as necessary and appropriate to enhance the 
effectiveness of FDA's regulatory programs.
    11. One comment stated that FDA should complete confidence building 
activities as expeditiously as possible and should devote adequate 
resources to that job.
    FDA agrees with this comment and, as stated previously, will devote 
resources to this program to the best of its ability.
    12. One comment noted that the proposed rule did not address FDA 
guidance documents and asked how guidance documents would be handled 
under the MRA and this regulation. The comment implied that some FDA 
guidance documents contain requirements.
    FDA will handle guidance documents under this MRA as it handles all 
guidance documents, according to FDA's Good Guidance Practices (62 FR 
8961, February 27, 1997). If FDA determines that there is a need for 
guidance documents under the MRA, it will publish them or refer to them 
as appropriate. FDA periodically makes available to the public lists of 
guidance documents and those that are relevant to the implementation of 
the MRA or this regulation will be referred to during such 
implementation. Guidance documents do not themselves contain 
requirements; they do sometimes refer to or explain requirements that 
exist in statutes or regulations.
    13. One comment expressed concern that the MRA and the proposed 
rule might result in lower health, safety, and environmental standards 
in both the United States and the EC. The comment expressed concern 
that the ``framework'' agreement might allow undue pressure to relax 
regulation in one sector of commercial activity in order to secure 
market access in another unrelated sector. Consequently, the comment 
asked FDA to seek ``the elimination of the umbrella framework 
agreement'' to ensure that U.S. health and safety standards are not 
compromised.
    FDA declines to take the action requested by the comment. The 
``framework'' agreement will not result in lower health or safety 
standards for FDA-regulated products. The MRA and this regulation 
expressly preserve the authority of a party to determine, ``through its 
legislative, regulatory, and administrative measures, the level of 
protection it considers appropriate for safety; for protection of 
human, animal, or plant life or health; for the environment; for 
consumers; and otherwise with regard to risks'' (MRA Article 15, 
``Preservation of Regulatory Authority,'' and Sec. 26.74 of this 
regulation).
    Additionally, this regulation expressly recognizes, at several 
places, that statutory and regulatory requirements applicable to drugs 
and devices remain in place unchanged (see, e.g., Sec. 26.1(b) 
(definition of ``equivalence'') see also Sec. 26.32(c) and 
Sec. 26.62(c) and that each party may take actions necessary to ensure 
the protection of human and animal health ``at the level of protection 
it deems appropriate'' (see Sec. 26.21; see also Sec. 26.74(a) and (b) 
(preservation of regulatory authority)).
    This position is consistent with both the statutes FDA administers 
and international agreements such as the Agreement on Technical 
Barriers to Trade which expressly recognizes that ``no country should 
be prevented from taking measures necessary to ensure the quality of 
its imports, or for the protection of human, animal or plant life or 
health, of the environment, or for the prevention of deceptive 
practices, at the levels it considers appropriate, subject to the 
requirement that they are not applied in a manner which would 
constitute a means of arbitrary or unjustifiable discrimination between 
countries where the same conditions prevail or a disguised restriction 
on international trade * * *.'' (See paragraph 6 of the preamble to the 
Agreement on Technical Barriers to Trade).
    FDA further notes that, under an MOU with USTR concerning the MRA 
(see the notice of availability for this MOU published elsewhere in 
this Federal Register), USTR will notify FDA of matters to be 
considered by the Joint Committee, which will be established to 
consider issues relating to the effective functioning of the MRA. While 
USTR normally will speak and vote for the United States in the Joint 
Committee, subject to arrangements with other agencies covered by the 
MRA, FDA will speak for and vote on behalf of the United States on any 
matter pertaining to FDA's statutory and regulatory authority. FDA will 
also represent the U.S. Government on such matters in any other 
committee or bodies with similar functions established under the MRA or 
its annexes. This MOU will ensure that, insofar as FDA-regulated 
products and issues are concerned, public health and safety issues are 
adequately considered and addressed.
    14. One comment strongly disagreed with FDA's position that a 30-
day comment period for the proposed rule was adequate. The comment was 
characterized as ``a preliminary identification of key issues involved 
in the [MRA or the proposed rule] process'' and requested that the 
comments be viewed as ``the beginning of an ongoing open process in 
which public comments will be considered at later junctures'' with 
future opportunities to discuss issues with FDA and other government 
officials.
    As stated in the preamble to the proposed rule (63 FR at 17744 at 
17747), FDA provided a 30-day comment period because a longer comment 
period was unnecessary in light of the numerous opportunities for 
public input the agency provided during the MRA negotiations. These 
opportunities included the creation of a public docket for MRA-related 
issues on May 9, 1996, dissemination of a document concerning the MRA 
on October 18, 1996 (including an opportunity for public comment on 
that document), public exchange meetings on March 31, 1995, and October 
30, 1996, a Transatlantic Business Dialogue (TABD) meeting on November 
8 and 9, 1996, which included a discussion of the MRA, and other public 
meetings on March 14, 1997, and September 23, 1997. The MRA itself was 
initialed by governmental representatives on June 20, 1997, and has 
been available on the World Wide Web (WWW) for over a year. Therefore, 
the agreement upon which the proposed rule was based had been available 
for analysis and comment by interested members of the public for some 
months. In view of these opportunities for public discussion and 
consideration of the MRA, the 30-day comment period for the proposed 
rule was adequate.
    FDA also stated that it was in the public interest to proceed 
expeditiously to implement the MRA, and that the 30-day comment period 
was not contrary to Executive Order 12889 (63 FR 17744 at 17747).
    As for the comment's remarks concerning future opportunities for 
public comment, the agency shares this interest and notes that the 
public has many avenues for contacting FDA on almost any issue. For 
example, a person may send a letter to the agency, request a meeting, 
submit a citizen petition to request issuance or revision of a

[[Page 60126]]

regulation or to request agency action or reconsideration on a 
particular matter, or submit comments on a document published in the 
Federal Register (see, e.g, 21 CFR 10.20, 10.30, 10.33, 10.65).
    In sum, FDA agrees that the agency will need to communicate with 
the public, on a regular basis, as the MRA is being implemented. 
Interested persons may submit comments on the MRA, or implementation of 
the MRA, to the agency at any time. In addition, as noted previously 
FDA's administrative practices and procedures regulations (21 CFR part 
10) provide a range of processes for interaction with the agency. 
Furthermore, the agency contemplates frequent meetings and other 
communications with the public as MRA implementation progresses.

B. Composition and Operation of the Joint Committees

    Several comments encouraged, or would revise the rule to provide 
for, opportunities for public, industry, or specific agency involvement 
in various programs or bodies established by the MRA and the proposed 
rule or by their operation.
    1. Four comments said that FDA should ensure industry or public 
access to and participation in the activities of the MRA and the 
proposed rule. Three comments advocated industry participation and 
suggested that FDA and the EC consult the industry during the 
transitional and operational phases of the confidence building stage. 
Two of these three comments specifically identified TABD as being 
critical or essential to implementing the MRA and the proposed rule. 
Another comment expressed the opposite view, i.e., concern about what 
the comment described as the TABD's involvement in the MRA 
negotiations. One comment asked FDA to ensure greater public 
participation and access for nongovernmental organizations in future 
mutual recognition agreement negotiations and throughout their 
implementation.
    The agency appreciates and values public and industry input and 
advice on many matters and intends to employ a variety of means to seek 
input from the public on the implementation of the MRA and this 
regulation. However, the MRA and its sectoral annexes represent an 
agreement between governments that contemplates examination of one 
another's equivalence in specific areas of regulation. Although FDA 
believes it would be inappropriate to amend the rule to require 
industry or consumer participation or the participation of specific 
industry or consumer representatives on delegations to meetings or to 
require FDA or the EC to consult industry, FDA plans to consult 
interested persons--whether they represent the industry, public 
interest groups, or any other interested person--at appropriate stages 
of implementation of the MRA and this regulation.
    As for the comment requesting greater public participation in 
future mutual recognition agreement negotiations and implementation, 
that request is outside the scope of this rule. However, we refer 
interested persons to ``A Plan that Establishes a Framework for 
Achieving Mutual Recognition of Good Manufacturing Practices 
Inspections,'' dated May 20, 1998 (see ``What's New on the FDA 
Website'') (``www.fda.gov/opacom/newonweb.html'').
    2. Four comments discussed representatives to either the Joint 
Committee or the Joint Sectoral Committee in proposed Secs. 26.17 and 
26.47 (``Role and Composition of the Joint Sectoral Committee'') and 
26.73 (``Joint Committee''). Three comments requested clarification as 
to which U.S. Government agencies would be represented on the Joint 
Committee or the Joint Sectoral Committees; two comments advocated 
including officials of USTR and the Department of Commerce on the Joint 
Sectoral Committees; and one comment recommended including EC trade 
offices on the Joint Sectoral Committees. All four comments advocated 
industry representation, or regular participation, in the Joint 
Committee and/or the Joint Sectoral Committees.
    FDA declines to amend the rule to describe which U.S. or EC 
governmental bodies will send representatives to meetings of the Joint 
Committee or Joint Sectoral Committees as requested by the comments. In 
general, the government representatives to either the Joint Committee 
or the Joint Sectoral Committees will vary depending upon the issues 
presented to those committees (see, e.g., Sec. 26.73(a) (stating that 
the Joint Committee consists of ``representatives'' of both parties) 
and Sec. 26.73(b) (authorizing the Joint Committee to establish Joint 
Sectoral Committees ``comprised of appropriate regulatory authorities 
and others deemed necessary''). Thus, each party has the flexibility to 
determine which government authorities should be present and to match a 
particular governmental authority's expertise to the issue or issues 
before a committee. Amending the rule so that either committee would 
have to include specific representatives of U.S. Government authorities 
would unnecessarily impair such flexibility, and it would be especially 
inappropriate for FDA to amend the rule to specify what representatives 
the EC would send to the committees.
    In any case, as explained in section II of this document, the USTR 
will normally speak for and vote on behalf of the United States in the 
Joint Committee, subject to arrangements with other agencies covered by 
the MRA, and FDA will speak for and vote on behalf of the United States 
on any matter pertaining to FDA's statutory or regulatory authority. 
Furthermore, the Joint Committee (when FDA is representing the United 
States) and the Joint Sectoral Committee likely will be addressing 
technical issues of the sort that FDA, not USTR or DOC, will be 
considering. The agency is confident that, in all cases, the 
composition of the Joint Committee or Joint Sectoral Committees will be 
appropriate for the topics being discussed.
    As for the comments seeking industry representation or 
participation in the Joint Committee or the Joint Sectoral Committees, 
FDA declines to revise the rule to require such industry representation 
or participation. Because the MRA, including its sectoral annexes, is 
an agreement between governments, it is neither necessary nor 
appropriate to amend the rule to include or to require nongovernmental 
entities or organizations on the Joint Committee or the Joint Sectoral 
Committees.
    3. One comment asked for clarification about the composition of the 
Joint Committee and asked whether U.S. citizenship is required for U.S. 
members.
    U.S. representatives addressing FDA topics will be FDA officials. 
Except in extremely rare circumstances, U.S. citizenship is a 
requirement for employment by FDA. European representatives will be 
European Commission officials, possibly accompanied by officials of 
member country regulatory authorities.

C. Transparency and Confidentiality Issues

    Several comments discussed the need for ensuring public or industry 
participation in equivalence or other regulatory matters under the 
rule. Other comments emphasized a need for withholding certain 
information, such as trade secrets and confidential commercial 
information, from public disclosure.
    1. One comment suggested that the rule contain a mechanism for 
public participation in the equivalence determination process. The 
comment would provide the opportunity for public comment or input 
throughout the 3-year transition period, as soon as FDA

[[Page 60127]]

decides which foreign regulatory systems and CAB's it will review to 
determine whether they are equivalent, and again when FDA makes a 
preliminary determination of equivalence. The comment also called for 
public notice in the Federal Register and a response to any public 
comments when FDA issues a final determination.
    FDA intends to hold periodic meetings with interested parties. FDA 
also plans to prepare and to make public summaries of key meetings held 
with its EC counterparts concerning implementation of the MRA and this 
regulation. Further, FDA will make available to the public the 
administrative file that constitutes the basis for any of FDA's 
equivalence determinations subject to exemptions from disclosure 
provided in the FOIA and restrictions in related statutory provisions 
discussed in the response to comment 2 in section II.C of this 
document. These approaches should give interested persons insight as to 
the information FDA considered when making an equivalence 
determination.
    FDA also will use the Federal Register and its Internet home page 
to make available information on equivalence determinations under the 
MRA and this regulation. Interested persons can submit comments on 
these determinations.
    The agency believes it is important that all interested parties 
have an opportunity to contribute to the equivalence assessment 
process. To facilitate such contribution, FDA intends to hold public 
meetings during the 3-year transition period. In addition, FDA invites 
all interested persons to provide the agency with information that is: 
(1) Generally relevant to implementation of the MRA and this 
regulation; and, (2) of particular relevance to equivalence criteria in 
Appendix D of subpart A of this rule, and their application to the 
authorities listed in Appendix B of subpart A of this rule. Information 
should be sent to the Dockets Management Branch (address above), and 
should be identified with docket number 95N-0185.
    2. Three comments would revise the proposed rule to ensure that the 
public has access to: Draft programs for assessing equivalence of a 
regulatory system under proposed Sec. 26.6(b); information provided by 
a foreign government concerning that government's regulatory activities 
under proposed Sec. 26.6(c); ``audit'' reports by European authorities 
submitted to FDA; or records of CAB's reviewed by a foreign government 
to the extent that such records would be publicly available if they 
were reviewed by FDA. One comment explained that public disclosure 
would ensure accountability and enable U.S. consumers to maintain 
confidence in an ``equivalent'' inspection system. One comment would 
also revise the proposed rule to state expressly that neither party may 
obstruct public access to information that is publicly available under 
the laws or regulations of that party.
    In contrast, four comments sought clarification concerning 
disclosure or confidentiality issues and proposed Sec. 26.76, such as 
whether reports between the parties would be subject to public 
disclosure under the FOIA; whether information provided to the EC would 
be subject to EC confidentiality policies; and whether alert or 
vigilance reports (required by proposed Sec. 26.50) exchanged between 
the parties as part of an ongoing investigation would be subject to 
public disclosure.
    FDA declines to revise the rule as suggested by the comments. Under 
Sec. 26.76(a) of this regulation and Article 17 of the MRA, each party 
agrees to maintain, to the extent required under its laws, the 
confidentiality of information exchanged under this regulation and the 
MRA. Trade secrets, confidential commercial or financial information, 
and information relating to an ongoing investigation are not subject to 
public disclosure (see Sec. 26.76(b)). Additionally, the parties may 
designate portions of information that it considers to be exempt from 
disclosure, and parties are to take all precautions reasonably 
necessary to protect information exchanged under the MRA and this 
regulation from public disclosure (see Sec. 26.76(c) and (d)).
    Those receiving information under the MRA will treat the 
information according to their domestic laws and policies. FDA will 
treat information it receives consistent with the FOIA, Privacy Act, 
and FDA's regulations and policies. EC Member States will treat 
information they receive according to the applicable laws in their 
respective territories. Therefore, information supplied to FDA by a 
foreign government or CAB and other information or documents discussed 
by the comments are subject to the rules on public disclosure (or 
nondisclosure) in the FOIA, the Privacy Act, parts 20 and 21 (21 CFR 
parts 20 and 21). FDA further notes that other laws, regulations, and 
agreements may provide additional safeguards against public disclosure 
of trade secrets and confidential commercial information. For example, 
section 301(j) of the act (21 U.S.C. 331(j)), in brief, prohibits any 
person from using to his or her own advantage or revealing trade secret 
information acquired by FDA under various provisions of the act. 
Article 39 of the Agreement on Trade-Related Aspects of Intellectual 
Property Rights (better known as the ``TRIPS'' agreement), to which the 
United States is a signatory, states that:
    Members, when requiring, as a condition of approving the 
marketing of pharmaceutical or of agricultural chemical products 
which utilize new chemical entities, the submission of undisclosed 
test or other data, the origination of which involves a considerable 
effort, shall protect such data against unfair commercial use. In 
addition, Members shall protect such data against disclosure, except 
where necessary to protect the public, or unless steps are taken to 
ensure that the data are protected against unfair commercial use.
These laws and agreements would also be applicable to information and 
documents acquired by FDA under the MRA and this regulation. 
Consequently, given the existence of various agreements, laws, and 
regulations pertaining to public disclosure and confidentiality, no 
revision to this rule is necessary.
    The public availability of the documents or information identified 
in the comments would, therefore, depend on whether they contained 
information that, under U.S. laws, regulations, or other obligations, 
is exempt from public disclosure. In some instances, portions of a 
document may be publicly available. For example, alert or vigilance 
reports under Sec. 26.50, when provided to FDA, would be available for 
public disclosure under Sec. 20.111 if the investigation of the 
reported incident has been completed; however, personal identifiers 
would be redacted, as FDA currently does under Sec. 20.111.
    3. Two comments would revise proposed Sec. 26.76 so that a person 
submitting information to FDA could decide whether all or part of the 
information is confidential or trade secret and therefore not subject 
to public disclosure.
    FDA declines to revise the rule as suggested by the comments. The 
agency believes this issue is handled adequately under current FDA 
regulations and policies. FDA policy is to make the fullest possible 
disclosure of records to the public, consistent with the rights of 
individuals to privacy, property rights in trade secrets and 
confidential commercial or financial information, and FDA's need to 
promote frank internal policy deliberations and to pursue regulatory 
activities without disruption (see Sec. 20.20). Under FDA regulations, 
marking records submitted to FDA as confidential raises no obligation 
by FDA to regard such records as confidential, to return them

[[Page 60128]]

to the person submitting the records, to review the records to 
determine whether all or part of them are available for public 
disclosure, or to withhold them from public disclosure (see 
Sec. 20.27). FDA determines whether data or other information are 
confidential and not subject to public disclosure, consistent with 
Sec. 20.28.
    4. One comment would revise proposed Sec. 26.76 so that trade 
secrets, ongoing investigations, and patient records are confidential.
    FDA declines to amend the rule as requested by the comment. Such a 
revision is unnecessary given current statutory and regulatory 
requirements involving public disclosure and confidentiality, including 
the prohibition in section 301(j) of the act against disclosure of 
trade secrets, all of which apply to information FDA receives from the 
regulatory authorities and CAB's.
    5. One comment would revise the rule so that a foreign country 
receiving documents from FDA would have to make those documents 
available to the U.S. public, even if the foreign country's laws would 
not make those documents publicly available. The comment would make 
information submitted to a foreign country available to the public if 
that information were publicly available in the United States.
    FDA declines to revise the rule as suggested by the comment. 
Requiring a foreign country to make information available to U.S. 
citizens when such disclosure would be contrary to the foreign 
country's own laws and regulations is beyond the scope of this 
rulemaking and beyond FDA's regulatory authority. In addition, the 
public availability in the United States of information provided to EC 
officials is already dealt with in FDA's regulations, particularly 
Sec. 20.89. (Under Sec. 20.89, disclosure of nonpublic information to 
foreign officials does not automatically result in that information 
being available to the public generally.)
    6. One comment would revise proposed Sec. 26.20 as it pertains to 
the application of the alert system against individual companies. The 
comment expressed concern about lack of transparency and due process 
before a company is placed in or removed from ``a negative regulatory 
status'' and suggested that the elements to be considered as part of 
the alert system be described.
    The comment misunderstands the purpose of the alert system 
provisions of the MRA and this regulation. The agency wishes to clarify 
that the purpose of the alert system is to implement a timely exchange 
of product quality information and not information on the regulatory 
status of inspected firms. The agency is keenly aware of the need to 
avoid predecisional or otherwise inappropriate regulatory 
classification of a firm or product. In implementing Sec. 26.20, FDA 
intends to apply the same standard of fairness and due process it 
currently affords to manufacturers with respect to regulatory matters. 
While keeping in mind the need to be fair to manufacturers, however, 
the agency must keep public health and safety paramount in ensuring 
that the alert system functions effectively to protect consumers from 
unsafe or ineffective products. Regarding ``transparency,'' as 
discussed in section II of this document, FDA will apply to the alert 
system established by the MRA and this regulation the applicable 
requirements as to disclosure and nondisclosure.
    The proposed rule did set forth the elements to be considered in 
developing a two-way alert system (see 63 FR 17744 at 17752), and the 
alert system is designed to serve as a means for notifying each party 
of crises and emergencies. For example, the documentation element for 
the two-way alert system refers to elements such as ``definition of 
crisis/emergency and under what circumstances an alert is required'' 
and ``mechanism of health hazards evaluation and classification'' 
(id.). The crisis management system element mentions ``crisis 
management and communication mechanisms,'' ``establishment of contact 
points,'' and ``reporting mechanisms.'' In short, the alert system does 
not place specific firms in a ``negative regulatory status'' or 
otherwise punish firms as the comment suggests.
    7. One comment asked about the confidentiality of submissions under 
the MRA, particularly submissions to medical device CAB's.
    Confidentiality by FDA and EC regulatory authorities is addressed 
under Article 17 of the MRA. Confidentiality concerns are also 
addressed in FDA's regulations (e.g., part 20) and guidance materials. 
FDA urges manufacturers to include clear and definitive language 
regarding their views on the confidentiality of submissions in 
contracts developed with CAB's. Just as submitters currently identify 
information they believe to be confidential commercial or trade secret 
information in submissions to the agency, they should clearly mark the 
same types of information in submissions to CAB's. Although FDA needs 
to make the final decisions as to confidentiality, as discussed 
previously in comment 3 in section II.C of this document, the 
contractual agreement between submitters and the CAB's should address 
the desired handling of information marked in this manner and 
contractual provisions should specifically address the need to share 
information with regulatory agencies participating in the MRA, 
including FDA.

D. Equivalence issues

    1. One comment recommended that equivalence determinations and 
suspensions of equivalence determinations should be made by the 
importing authority only, rather than jointly by the parties to the MRA 
and the proposed rule. The exporting country should develop the case 
for equivalence, while the importing country should have complete 
control over the final equivalence decision. This would maintain the 
importing country's sovereign prerogative to protect the health and 
safety of its citizens.
    FDA agrees that the importing authority must have control over the 
decision as to whether the exporting authority is equivalent, and the 
agency believes that the decision-making process set up by the MRA and 
this regulation provides adequately for this. The MRA and this 
regulation stipulate that equivalence determinations will be made by 
the Joint Sectoral Committee, which consists of representatives of the 
parties. This regulation states that decisions of the Joint Sectoral 
Committee ``will be taken by unanimous consent'' (Secs. 26.17(b) and 
26.47(b)). Therefore, no equivalence determinations can be reached in 
the Joint Sectoral Committee without concurrence by both sides. Hence, 
in all cases, the relevant authority of the importing country (FDA, in 
the case of imports into the United States) will have definitive 
decision making authority.
    Similarly, the importing party's right to determine that an 
equivalence determination should be suspended is also protected by the 
MRA and this regulation. Decisions to suspend equivalence are taken in 
the Joint Sectoral Committee, and when that Committee cannot reach 
unanimous consent on the appropriate action, the matter is referred to 
the Joint Committee. (As discussed earlier, FDA officials will speak 
for, and vote on behalf of, the U.S. Government on any matter 
pertaining to FDA's statutory or regulatory authority raised within the 
Joint Committee or Joint Sectoral Committees.) If unanimous consent is 
not reached within a set time period in the Joint Committee, the 
contested authority must be suspended. Thus, if

[[Page 60129]]

during these deliberations, the importing authority remains convinced 
that an exporting authority's equivalence determination should be 
suspended, the contested authority will be suspended even if the other 
party disagrees.
    Furthermore, the importing country's sovereign prerogative to 
protect the health and safety of its citizens is further protected for 
pharmaceuticals by Sec. 26.21 and for medical devices by Sec. 26.67(f). 
Section 26.21 provides that a party may, if necessary to ensure the 
protection of human and animal health at the level of protection it 
deems appropriate, take actions such as suspension of the distribution 
of the pharmaceutical, product detention at the border of the importing 
country, withdrawal of the batches and any request for additional 
information or inspection as provided in Sec. 26.12. Section 26.67(f) 
provides that a party may, prior to the suspension of a CAB, cease 
accepting the results of conformity assessment procedures performed by 
that CAB if the decision for such action is made on the basis of 
health, safety or environmental considerations, among others. The 
``framework'' of the MRA and this regulation also contain a provision 
(Article 15 and Sec. 26.74, respectively) preserving domestic 
legislation.
    2. One comment stated that equivalence determinations must be based 
on an exacting review of the foreign regulatory system. This comment 
emphasized that equivalence should be determined to exist only where a 
finding can be made that the foreign system meets or exceeds the level 
of public health protection, enforceability, transparency, and 
effectiveness of the U.S. system.
    FDA agrees with this comment, and intends to carry out a careful, 
detailed, and complete review of foreign regulatory systems in order to 
determine whether equivalence does, in fact, exist. FDA's review will 
examine whether the foreign system, as it is implemented by the 
exporting authority, provides the same (or a higher) level of public 
health assurance as the FDA system. The enforcement activities of the 
foreign regulatory system and the foreign system's effectiveness in 
assuring public health protection are very important components of the 
overall equivalence analyses. For pharmaceuticals, they are 
specifically covered in subpart A of this regulation, Appendix D, 
Subsection I (Criteria for Assessing Equivalence for Post- and 
Preapproval). Criterion I. (Ability to enforce requirements and to 
remove products found in violation of such requirements from the 
market) and Criterion V. (Execution of regulatory enforcement actions 
to achieve corrections, designed to prevent future violations, and to 
remove products found in violation of requirements from the market) 
focus on the execution of regulatory enforcement actions. All of the 
criteria taken as a whole cover the public health protection and 
effectiveness of the foreign system. In addition, Criterion I. F. 
(Accountability of the regulatory authority) relates to transparency, 
in that there must be a system through which the regulatory authority 
is accountable for its actions. Similar criteria will be developed and 
applied for competent authority oversight of medical devices. FDA 
expectations as to medical device CABs' reviews of premarket 
evaluations are set forth in a guidance document announced in the 
Federal Register of July 2, 1998 (63 FR 36240).
    3. One comment requested clarification of equivalence assessment 
(Sec. 26.6) and asserted that enforcement and regulatory compliance 
systems between the United States and the EC need to be comparable. The 
comment explained further that, before assessments can be made, local 
regulations for pharmaceutical manufacturing should be in place. The 
comment added that EC countries have not issued and made public such 
regulatory documents as warning letters, to identify unacceptable 
manufacturers.
    The agency emphasizes that, as stated in the definition of 
equivalence, to be equivalent to the United States, EC regulatory 
authorities need to be ``sufficiently comparable to assure that the 
process of inspection and the ensuing inspection reports will provide 
adequate information to determine whether respective statutory and 
regulatory requirements of the authorities have been fulfilled.'' 
(Sec. 26.1(c)). However, ``[E]quivalence does not require that the 
respective regulatory systems have identical procedures.'' Furthermore, 
among the criteria for assessing equivalence, contained in Appendix D 
of subpart A, is the ``[A]bility to enforce requirements and to remove 
products found in violation of such requirements from the market'' and 
``[A]ccountability of the regulatory authority.'' The agency expects 
that these two criteria, in combination with others in Appendix D, 
should address the comment's concerns.
    The agency does not understand the comment's apparent premise that, 
before assessment can commence, regulatory systems must already be 
comparable. The agency intends to assess the equivalence of an 
authority based upon the criteria in Appendix D of subpart B as they 
exist at the time the agency makes the assessment, and needed steps can 
be taken to address any shortcoming noted.
    4. One comment emphasized the need to assure a level playing field 
in terms of inspectional activity (i.e., the length and frequency of 
inspections and the number of auditors). This comment recommended 
collection of statistics about these activities during the transition 
period and then steps to ensure a reasonable harmonization in 
approaches between European and FDA audits.
    FDA agrees with this comment. Equivalence must exist not only in 
the foreign authority's legislation and written procedures (including 
those concerning audits), but also in the manner in which these 
policies are actually implemented. Under the MRA and this regulation, 
the conduct of inspections is one of the criteria (Criteria IV) that 
must be considered in reaching equivalence determinations for 
pharmaceuticals.
    5. One comment questioned how the MRA and the proposed rule would 
stop a country from relaxing its standards to create an industry-
friendly regulatory environment within its jurisdiction, resulting in 
movement of industry from countries with strict enforcement to 
countries of less strict enforcement.
    There are limits to what governments can do to influence corporate 
choices about location or relocation of manufacturing sites; many 
factors play a part in these corporate choices. In any case, the MRA 
and this regulation have several mechanisms to help prevent ``a race to 
the bottom'' with respect to regulatory controls. First, the process 
for ascertaining equivalence will be rigorous. Second, after an 
equivalence determination has been made, Article 18 of the Sectoral 
Annex for Pharmaceutical GMP's (Sec. 26.18 of this regulation) and 
Article 19 of the Sectoral Annex for Medical Devices (Sec. 26.49 of 
this regulation) provide that the parties and authorities are to inform 
and consult one another, as permitted by law, on proposals to introduce 
new controls or to change existing technical regulations or inspection 
procedures, and to provide the opportunity to comment on such 
proposals. Furthermore, the parties must notify each other in writing 
of any changes to relevant legislation, regulations, and procedures. 
Third, Article 15 of the MRA and Sec. 26.15 of this regulation provide 
for monitoring activities for the purpose of maintaining equivalence. 
Fourth, either side may refrain from ``normally endorsing'' audit 
reports or device evaluation reports if regulation is

[[Page 60130]]

insufficiently strict. Fifth, if FDA believes that the foreign 
authority has made changes to its control system that lessen the 
equivalence of that system, FDA has the right to contest the 
equivalence of that regulatory authority.
    Although the MRA and this regulation cannot prevent an exporting 
country from relaxing its standards, the MRA and this regulation ensure 
that the importing country must be notified, the equivalence 
determination of the exporting country can be suspended, and importing 
countries can take needed actions to protect their citizens.
    6. One comment offered support for the proposed rule's recognition 
that an equivalence assessment must include joint training and joint 
inspections. This comment emphasized that the MRA and the proposed rule 
should provide for monitoring and verification of on-going equivalence, 
including on-going training, on-going joint inspections, and periodic 
on-going visits.
    FDA agrees with this comment. This regulation, as currently 
drafted, provides for such monitoring and verification in Sec. 26.15 
for pharmaceuticals and Sec. 26.69 for medical devices. In the case of 
medical devices, Sec. 26.69 does not specifically mention training, but 
also does not exclude it. Joint training exercises are listed in 
Sec. 26.37 as a confidence building activity during the transition 
period, and FDA considers monitoring and verification of on-going 
training to be an essential element of verifying that equivalence 
continues to exist.
    7. One comment stated that the MRA and the proposed rule should 
provide for periodic expiration of an equivalence determination within 
3 to 5 years following the initial determination. FDA should then 
publish a notice in the Federal Register for public comment on whether 
the equivalence determination has worked and should be renewed. Before 
renewing the equivalence determination, the United States should verify 
that the foreign country's or CAB's procedure continues to be 
equivalent.
    FDA agrees that periodic reexamination of a foreign system that has 
been found equivalent is a prudent practice to ensure that equivalence 
continues to exist. The agency intends to provide for monitoring of 
continued equivalence in its implementation of equivalence 
determinations arrived at under the MRA and this regulation. However, 
the agency does not believe it necessary to require a ``sunset'' 
provision for periodic reexamination of equivalence in the MRA or this 
regulation. FDA will consider how to provide for reexamination of 
equivalence during implementation of the MRA.

E. ``Piggy back'' Agreements

    1. One comment suggested that the MRA and the proposed rule should 
prohibit the development of what the comment called the ``piggy-back 
dilemma'' because they would set a precedent for these types of 
arrangements. The comment described an example of such a ``piggy-back'' 
arrangement as FDA establishing a mutual recognition agreement with 
country A, country A then establishing a mutual recognition agreement 
with country B, and then FDA automatically granting a mutual 
recognition with country B on the basis of its mutual recognition 
agreement with country A.
    FDA disagrees with the comment's conclusion that the MRA and this 
regulation would set a precedent for entering into such ``piggy-back'' 
arrangements. The MRA and this regulation require a determination of 
equivalence be made by FDA of each EC Member State regulatory authority 
and each device CAB located in EC Member States before any inspectional 
or evaluation reports would be ``normally endorsed'' by FDA under 
certain conditions. There are no provisions in the MRA or this 
regulation for the ``normal endorsement'' of reports from any countries 
or CAB's that have not been determined to be equivalent by FDA.
    2. One comment strongly opposed what the comment called ``piggy 
back equivalence'' as described in the proposed rule under 
Sec. 26.11(b) because it would take away FDA's authority to make its 
own equivalence determinations and otherwise compromise its ability to 
ensure public health.
    The so-called ``piggy-back'' or ``surrogate'' inspections described 
in Sec. 26.11(b) provide that FDA may ``normally endorse'' inspection 
reports resulting from joint inspections by an equivalent authority and 
a nonequivalent authority of manufacturers located in the nonequivalent 
authority's territory. Under the provisions of the MRA and this 
regulation, FDA has the option of participating in all ``surrogate'' 
inspections and expects to exercise this right as necessary. 
Furthermore, the MRA and this regulation have other safeguards in place 
for these types of inspections, and more generally as described 
previously, that ensure public health protections are maintained.

F. Pharmaceutical issues

    1. One comment stated that if FDA has confidence that the EC can 
regulate drug substances, biologics should also be included in the 
scope of the document.
    Many biological products, such as vaccines and therapeutic drug 
products, are included in the scope of the MRA and this regulation. 
Other biological products, specifically human blood, plasma, tissues 
and organs, were excluded from the scope of the MRA. In order for there 
to be a finding of equivalence, the parties to the MRA and this 
regulation must have sufficiently comparable regulatory systems for the 
products. Not all EC Member States have established regulatory systems 
for human blood, plasma, tissues, and organs at this time, so it would 
not be possible to have a finding of equivalence during the transition 
period for these products. Plasma derivatives were excluded from 
initial consideration because the U.S. regulation of plasma derivative 
products has recently undergone intense scrutiny and regulatory change; 
therefore, the FDA did not believe it appropriate at this time to 
include plasma derivatives within the scope of the MRA and this 
regulation.
    2. One comment suggested that Sec. 26.1 of the proposed rule be 
amended to include a definition for the term ``normally endorsed.''
    The agency believes that a codified definition of ``normally 
endorsed'' is not needed because the rule (at Sec. 26.12) exemplifies 
circumstances in which the reports would not be normally endorsed. 
However, FDA wishes to clarify that normal endorsement generally means 
that an authority will accept the information contained in the 
inspection report to evaluate and determine a manufacturer's compliance 
with that authority's requirements, and FDA expects to endorse the 
finding in the reports most of the time. FDA is not, however, prevented 
from reaching different conclusions in appropriate circumstances.
    3. One comment suggested revisions to the definition of GMP's 
(Sec. 26.1(c)(1)) to explicitly include packaging, labeling, testing, 
and quality control.
    FDA believes the suggested revisions are unnecessary. Labeling, 
testing, quality control, and packaging are part of manufacturing. FDA 
believes that the proposed definition meets the needs of part 26 
because it is consistent with FDA's statutes and regulations.
    4. One comment said that the proposed definition of ``inspection 
report'' (Sec. 26.1(e)) was inconsistent with

[[Page 60131]]

the definition of ``inspection'' because it lacked reference to report 
coverage of commitments made as part of the approval to market a 
product. The comment suggested added wording to include such 
commitments.
    The agency believes it unnecessary to modify the definition of 
``inspection report,'' as suggested, because it should be clear from 
other sections of the rule (such as Secs. 26.2, 26.3, and 26.14), that 
FDA fully expects that reports covering preapproval inspections of drug 
manufacturers will, as a matter of course, include information relating 
to commitments made as part of the marketing approval. In addition, as 
stated in Sec. 26.8, the agency intends to work quickly with 
counterpart authorities under the MRA to determine inspection report 
contents and format.
    5. One comment suggested that the proposed rule clarify that it 
would apply only to inspection of firms that are exporting covered 
pharmaceutical products from either of the two regions to the other.
    The agency believes that the current wording in Sec. 26.3 is 
sufficiently clear to limit the scope of inspections to only those 
firms located in the two regions. The rule states in relevant part that 
the ``provisions of this subpart shall apply to pharmaceutical 
inspections carried out in the United States and Member States of the 
European Community* * *.'' Furthermore, Sec. 26.12 refers to inspection 
reports being normally endorsed by the importing (emphasis added) 
party. Clearly, the importing party is interested in only inspection 
reports because of products being imported into its territory.
    6. One comment suggested changing the word ``both'' to ``either'' 
in Sec. 26.4(a) on the grounds that a product regulated as a drug by 
one party but not the other should not be excluded from this regulation 
because at least one party will apply current GMP standards to the 
product.
    The agency disagrees with the suggestion. If an importing country 
regulates an article as a drug, but the exporting country does not, the 
importing country would likely hold the article to a different (higher) 
set of manufacturing standards. In such a situation, it is unlikely 
that the importing country would find the exporting country's 
inspection report of value in assessing the manufacturer's compliance.
    7. One comment objected to the provision in Sec. 26.6(c) that 
equivalence assessments mandate joint inspections. The comment 
suggested that they be minimized or replaced by ``accompanied 
inspections'' where the lead authority is clearly designated.
    FDA believes that the conduct of joint inspections is an essential 
part of the equivalence assessment process. Such assessments would be 
incomplete without first hand observation of how an authority conducts 
an inspection. The agency wishes to clarify that, as stated in the 
rule, the conduct of joint inspections is ``for the purpose of 
assessing regulatory systems and the authorities' capabilities.'' The 
actual format of the joint inspections has not yet been determined, and 
may include inspections where one party observes the other party's 
inspectional conduct or where each party has responsibility for part of 
the inspection. As part of the preparation for implementation of the 
MRA and this regulation, FDA expects to jointly develop with the EC a 
standard operating procedure for joint inspection that embodies this 
approach.
    8. One comment said the second sentence in Sec. 26.6(a) (stating 
that the EC will provide information pertaining to criteria under EC 
competence) was problematic because the equivalence criteria in 
Appendix D should be complete, as is, or else augmented, as needed.
    The agency believes the comment may have misinterpreted the 
proposed rule to mean the EC will be held to different, yet to be 
specified, equivalence criteria. The agency wishes to clarify that the 
equivalence criteria in Appendix D apply equally and fully to both 
parties. The sentence at issue addresses information (e.g., European 
Commission Directives) that the EC will provide relating to these 
criteria that applies to all Member State authorities, versus 
information that is specific to a particular Member State as to how 
Member State authorities meet these criteria.
    9. One comment said Sec. 26.6(b) should address the mechanism by 
which the parties establish and communicate their draft equivalence 
assessment programs. The comment called for interested parties to have 
the opportunity to comment on the draft programs before they become 
official. The comment also suggested that the phrase ``as deemed 
necessary'' would for FDA be in conflict with legislative mandates that 
require certain pre- and postapproval inspections.
    The agency does not believe it is necessary to codify the mechanism 
by which the parties establish and communicate their draft equivalence 
assessment programs. The parties have yet to establish those logistics. 
Regarding the opportunity for public input on such programs, as 
discussed in section II of this document, the agency intends to provide 
for such input in a manner consistent with current policy development 
and FOIA requirements. The agency is fully aware of its legislative 
mandates regarding establishment inspections and does not believe the 
wording of the MRA or the rule is inconsistent with those 
responsibilities. FDA intends to carry out all activities that it deems 
necessary to be consistent with its responsibilities.
    10. One comment suggested adding wording to Sec. 26.8 to state that 
FDA will use its current inspection report format, or some modification 
thereof, until the parties develop and agree upon an inspection report 
format.
    The agency believes the suggested wording is unnecessary because it 
is confident that the parties will develop and agree upon a mutually 
acceptable report format in a timely manner.
    11. One comment suggested that Sec. 26.9(a) be revised to 
explicitly require FDA to use International Organization for 
Standardization (ISO) 9000 and ISO 10000 standards to determine that an 
authority has demonstrated a pattern of consistent performance with the 
criteria in Appendix D.
    The agency believes it is unnecessary to apply precise statistical 
methods in demonstrating a pattern of consistent performance, in the 
context of complying with Appendix D. The agency intends to apply 
objective and fair criteria in evaluating whether an authority has 
demonstrated a pattern of consistent performance but does not believe 
its already rigorous GMP and inspection requirements need an added 
``layer'' of requirements based upon the ISO standards mentioned.
    12. One comment suggested that Sec. 26.11(c) be amended to include 
a manufacturer's certification that the product was manufactured in 
accordance with applicable GMP's.
    FDA's view is that such a certification is unwarranted. The agency 
expects that, in the context of this agreement, authorities would rely 
upon inspectional reports to determine a manufacturer's current GMP 
compliance rather than relying upon the manufacturer's own declaration. 
The agency therefore declines to adopt the suggestion.
    13. One comment suggested adding a new paragraph, to complement 
Sec. 26.11(c), that would exempt U.S. manufacturers from carrying out 
all of the quality controls specified in the current GMP regulations, 
provided that the controls specified in Article 22 paragraph 1(b) of 
Council Directive 73/319/EEC have been carried out in the EC and each 
batch or lot is accompanied by

[[Page 60132]]

certificates of current GMP and marketing authorization compliance.
    FDA does not believe it is in the public interest to exempt 
manufacturers from performing currently required current GMP quality 
control measures, or to allow products to be released for distribution 
without requisite laboratory determination of conformance to 
established specifications. The suggested changes are not adopted.
    14. One comment suggested revisions to Sec. 26.13 to explicitly 
require that: (1) Requests for postapproval inspections include the 
product and the requester's areas of special concern; and (2) when new 
inspections are needed the authority receiving the request should state 
the reasons why a new inspection is needed along with the estimated 
completion date.
    The agency does not believe it is necessary to make the suggested 
modifications. The agency anticipates that, as a matter of course, 
inspection requests and corresponding communication will identify 
products, areas of concern, and other relevant information, as needed.
    15. One comment suggested revising Sec. 26.14(b) to require the 
notified authority to advise the requesting authority of approximately 
when the inspection will be completed, and to require the requesting 
authority at that point to detail what issues need to be addressed 
during the inspection.
    The agency declines to accept the suggestion because it believes 
such operational logistics will be performed as a matter of course, and 
need not be codified.
    16. One comment suggested revising Sec. 26.15 to specify that 
review of reports includes evaluation mechanisms such as tracking 
trends and problems and to state that review studies be used to focus 
on needed training and program improvements.
    The agency agrees that report evaluation and trending, along with 
coordination among the authorities to ensure program improvements, have 
merit. The agency does not, however, believe it is necessary to codify 
details of how equivalence monitoring will be performed.
    17. With regard to Sec. 26.18, one comment asked how changes in 
current GMP regulations and initiation of new programs, such as the 
First Party Audit Program (FPAP), would affect the implementation of 
the MRA and the proposed rule.
    The agency advises that, under Sec. 26.18, FDA will inform, consult 
with, and offer the opportunity for comment by, the other party, as 
permitted by law, regarding changes in current GMP regulations or 
inspection procedures. The mechanisms for conducting that collaboration 
have yet to be developed. Regarding the FPAP, the subject of an FDA 
public meeting held on June 23, 1998 (see 63 FR 27583, May 19, 1998), 
the agency advises that this initiative is currently in very early 
stages of development. However, conceptually, FPAP is intended to 
gather information from selected human use pharmaceutical manufacturers 
regarding their quality assurance measures; the information would be 
submitted to FDA by those firms and could substitute, in some measure, 
for information the agency would otherwise obtain from its direct 
inspectional activities. The agency cannot predict how these 
initiatives will affect the nature and volume of current GMP 
inspections performed under the MRA and this regulation. However, the 
agency will consult with the other party, in accordance with the 
provisions of this rule and the MRA itself.
    18. One comment suggested revising Sec. 26.18(b) to establish a 30-
day timeframe for the United States to notify the EC of any changes to 
Appendix B, and a 5-day timeframe where such notification can be made 
electronically.
    The agency intends to promptly notify the EC of changes to Appendix 
B, and to use electronic means of doing so whenever feasible. However, 
FDA believes it is unnecessary to codify specific timeframes.
    19. One comment suggested revising Sec. 26.19 to add reporting 
timeframes of 15 days for paper correspondence or 3 days for electronic 
correspondence.
    FDA shares the comment's concern regarding the timeliness of 
exchanging information relating to quality problems, and intends to 
implement such exchange in a prompt manner to be arranged in concert 
with the EC. FDA does not, however, believe it is necessary to codify a 
specific timeframe.
    20. One comment suggested revising Sec. 26.20(a) to establish 
reporting timeframes of 5 days for paper correspondence or 3 days for 
electronic communications.
    As discussed in response to comments on Sec. 26.19, the agency 
agrees that reporting needs to be done promptly, but does not agree 
with the suggestion.
    21. One comment asked if, and how, the MRA and the proposed rule 
will accommodate the collection of regulatory samples during 
pharmaceutical inspections.
    The agency advises that the MRA and this regulation do not specify 
how regulatory samples collected during establishment inspections will 
be handled. However, FDA anticipates that both parties will handle such 
samples as they currently do, and that information about such samples 
would be contained in the inspection report or related documents. The 
agency is prepared to work with the regulatory authorities should it 
become necessary to develop procedures relating to sample collection.
    22. One comment noted that a recent U.S. General Accounting Office 
(GAO) report on FDA's foreign inspection program included 
recommendations intended to improve management of the agency's overseas 
inspection program. The comment asked if FDA's consideration of the 
report would affect the MRA or the proposed rule.
    The agency has, in response to the GAO report, already initiated 
several modifications in the management of its overseas inspection 
program. The agency does not at this point anticipate that 
implementation of those changes will have a significant effect on the 
MRA or this regulation.
    23. One comment suggested adding a new paragraph to subpart C, 
Sec. 26.76 that would explicitly prohibit the parties from obstructing 
public access to information which, by U.S. law, is disclosable to the 
public.
    The agency does not agree that this section is needed because part 
26 does not conflict with U.S. laws regarding public access to 
information. The agency is fully aware of its legal obligations to 
abide by those applicable statutes, as discussed in section II of this 
document.
    24. One comment suggested numerous editorial changes to add clarity 
throughout the rule.
    The agency has carefully considered the suggested revisions and 
believes that although some have merit, on balance, the need to retain 
wording in part 26 that is as close as possible to the MRA itself 
outweighs the advantages that the changes might afford.

G. Medical Device Issues

    The Food and Drug Administration Modernization Act of 1997 (FDAMA), 
Pub. L. 105-115, 111 Stat. 2296 (1997), included a number of amendments 
to the act relevant to the MRA's Sectoral Annex on Medical Devices 
(Medical Devices Annex). First, an FDA pilot program for third-party 
review of medical devices (see 61 FR 14789, April 3, 1996) was codified 
in the act as new section 523 (21 U.S.C. 360m), entitled ``Accredited 
Persons.'' In the Federal Register of May 22, 1998 (63 FR 28392), FDA 
published a notice of availability of a draft guidance on its third-
party

[[Page 60133]]

accredited persons program under this new section of the act.
    Interested persons should also refer to a related notice of 
availability published in the Federal Register of July 2, 1998 (63 FR 
36240), entitled ``Draft Guidance for Staff, Industry and Third 
Parties, Third Party Programs under the Sectoral Annex on Medical 
Devices to the Agreement on Mutual Recognition Between the United 
States of America and the European Community; Availability'' (MRA). 
This guidance document is also available in FDA's Home Page on the WWW 
(``www.fda.gov'').
    Second, due to amendments made by FDAMA, FDA has exempted a number 
of devices from premarket notifications under section 510(k) of the act 
(21 U.S.C. 360(k)) (see 63 FR 3142, January 21, 1998 (Class II 
devices), and 63 FR 5387, February 2, 1998 (Class I devices)). On May 
20, 1998, FDA made available a list of devices which are eligible for 
third party review under new section 523 of the act. FDA plans to 
propose to the European Commission that the tables attached to the 
Medical Devices Annex to the MRA, listing devices eligible for review 
during the transitional period of the MRA, be revised to reflect the 
changes in U.S. requirements made by FDAMA and the FDA implementing 
actions described previously. The EC may also suggest changes 
concerning devices eligible for the MRA. These adjustments will be made 
during the transitional period under the MRA.
    Third, as discussed in comment 9 of section II.F of this document, 
FDA now has explicit authority to recognized voluntary consensus 
standards for devices due to a FDAMA amendment to section 514 (c) of 
the act (21 U.S.C. 360d(c)).
    1. One comment identified a typographical error in Table 1 of the 
Sectoral Annex on Medical Devices (Annex) of the proposed rule 
concerning radiographic screens Sec. 892.1960 (21 CFR 892.1960).
    FDA agrees with the comment and in the final rule has corrected 
this typographical error. Also, several minor typographical errors in 
the device lists were identified by the European Commission and FDA 
just prior to the signing of the MRA on May 18, 1998. These corrections 
are also being made in corresponding provisions in this rule.
    2. One comment from a manufacturer questioned whether condoms are 
covered by the MRA.
    The list of devices that FDA made available on May 20, 1998, for 
eligibility in the accredited persons program under section 523 of the 
act includes condoms, with and without spermicidal lubricant. 
Therefore, FDA is willing to consider condoms with or without 
spermicidal lubricant as eligible for participation in the premarket 
assessment component of the device MRA, if the EC agrees. Condoms 
without spermicidal lubricant are listed in Table 3 of the Annex for 
possible inclusion in the scope of product coverage during the 
Operational Period. However, condoms with spermicidal lubricants may be 
regulated by the EC, or certain EC Member States, as pharmaceuticals 
and hence may be outside the scope of the Medical Devices Annex.
    3. One comment asked whether clearance of a 510(k) will be 
equivalent to CE marking.
    Clearance of a 510(k) will not be considered equivalent to the CE 
marking, nor will CE marking be considered equivalent to a 510(k). 
Under the MRA and this regulation, the exporting country's CAB's 
perform specified conformity assessments in accordance with the 
importing country's requirements. The MRA and this regulation are 
intended to enable determinations: (1) Whether CAB's in the EC are 
capable of conducting certain premarket and quality system evaluations 
in accordance with U.S. regulatory requirements in a manner equivalent 
to how those evaluations are conducted by FDA (with FDA making the 
final decision, but with an expectation that FDA would ``normally 
endorse'' a CAB's assessment), and (2) whether CAB's in the United 
States are capable of conducting certain premarket and quality system 
evaluations in accordance with EC regulatory requirements in a manner 
equivalent to those conducted by European CAB's, also referred to as 
``notified bodies.''
    4. One comment requested implementation of a system by which U.S. 
manufacturers can obtain government documents for presentation to the 
EC.
    Appendix A of subpart B contains addresses the relevant 
legislation, regulations, and procedures for the EC and the United 
States. In addition, the European Commission has a site on the WWW for 
direct access to EC documents (``http://Europa.eu.int/eur-lex''). Also, 
just as European notified bodies are frequently a manufacturer's first 
point of contact regarding the process for meeting the European 
requirements, it is expected that, under the MRA and this regulation, 
U.S.-based CAB's will be able to provide manufacturers with information 
on EC requirements and copies of necessary European documents needed to 
meet European requirements.
    5. One comment stated that industry would like to encourage 
observed audits. The comment explained that, in an observed audit, a 
U.S. manufacturer would allow an EC Notified Body representative to 
accompany an FDA inspector during an inspection of its plant.
    FDA agrees that joint industry audits are necessary to demonstrate 
that CAB's are competent to assess medical devices to each country's 
requirements and level of public health protection. FDA encourages 
manufacturers to support observed audits.
    6. One comment suggested that, to further strengthen confidence in 
CAB's, training on auditing should be conducted by the United States 
and EC, and industry should be encouraged to participate in FDA's third 
party system, i.e., the accredited persons program.
    FDA agrees with the suggestions. Training on premarket and quality 
system evaluations is planned for CAB's participating in the MRA and in 
FDA's third-party accredited persons program. FDA has made tentative 
plans to conduct training for EC CAB's on October 14 to 16, 1998, in 
the Washington, DC area. Representatives of EC CAB's interested in 
participating in the MRA should begin making plans to attend this 
training, which is also being provided to participants in the 
accredited persons program. This training is intended to address the 
scope, content, and expectations of the evaluations sufficient to 
determine the equivalence of the assessments.
    7. One comment requested that FDA consider IV catheters, under 21 
CFR 880.5200, for inclusion in Table 2, ``Class II Medical Devices 
Included in Scope of Product Coverage at Beginning of Transition 
Period.''
    During the negotiation of the Annex, there were no expressions of 
interest in adding IV catheters to any of the tables of eligible 
medical devices. FDA is willing to consider that issue in the future, 
but at this time does not intend to include IV catheters in Table 2 at 
this time.
    8. Several comments suggested that the MRA be expanded to include 
more devices, including class II devices.
    As discussed previously, FDA plans to propose expansion of the list 
of eligible devices to include all devices eligible for third party 
review under FDAMA, except those medical devices regulated as in vitro 
diagnostics. (The EC does not yet have legislation in place on in vitro 
diagnostics.) The agency is considering specific suggestions by 
industry comments for inclusion of specific devices. These suggestions 
are extremely useful for future decisions,

[[Page 60134]]

although neither the FDA nor the European Commission can, at this time, 
respond to these industry suggestions by including additional devices 
under the MRA. Revision of the list will, however, be a step taken 
early during the transition stage. The pace at which devices can be 
added to the device premarket assessment aspect of the MRA depends on 
the availability of guidance documents or FDA-recognized standards, as 
discussed in comment 8 of section II.G of this document.
    9. Several comments urged FDA to accept international standards, 
instead of developing FDA guidance documents, for the third party 
review of class II devices. One comment proposed use of 81 
international and regional standards to support premarket evaluations 
and quality system evaluations.
    FDA, under FDAMA, has begun to recognize consensus standards for 
use in its various medical device activities (see 63 FR 9561, February 
25, 1998). FDA very much appreciates the submission identifying 
potentially useful standards. Communications such as this that relate 
to the use of standards in MRA implementation and other device 
activities are being considered in regard to FDA's consensus standards 
initiative announced on February 25, 1998. FDA plans to update the 
guidance for the recognition and use of consensus standards, as 
described in the February 25, 1998, document, and in doing so the 
agency will take into account the suggestions received and the 
information and experience to be gained during the implementation of 
the MRA.
    FDA's views on the appropriateness of including a device under the 
premarket evaluation component of the MRA will depend, in part, on 
whether FDA-recognized standards or review guidance documents exist to 
provide a basis for product evaluation. Recognized standards or review 
guidance do not currently exist for many of the additional devices 
suggested for inclusion in the MRA by certain industry comments. FDA 
plans to develop guidance documents only where recognized consensus 
standards fail to address sufficiently the requirements for 
demonstrating substantial equivalence or other U.S. requirements.
    10. One comment suggested that FDA take aggressive steps to 
identify and designate third party review organizations.
    FDA is proceeding in a timely and transparent manner to describe 
processes and expectations for third parties to participate in both the 
accredited persons program and the MRA. For example, the agency, in the 
Federal Register of July 2, 1998 (63 FR 36240), issued a comprehensive 
guidance document entitled ``Draft Guidance for Staff, Industry and 
Third Parties, Third Party Programs Under the Sectoral Annex on Medical 
Devices to the Agreement on Mutual Recognition Between the United 
States of America and the European Community (MRA),'' to assist 
interested parties to understand the designation process for CAB's and 
to prepare their applications. This document has been made available on 
the CDRH Home Page on the WWW. FDA officials also have discussed the 
third party programs under FDAMA and the MRA at trade shows and public 
meetings.
    11. Two comments suggested that both quality system evaluation 
reports and premarket evaluation reports should be harmonized between 
the United States and EC. Another comment stated that one of the issues 
to be resolved is determining what duration of an audit is satisfactory 
to the designating authorities as well as the scope, content, and 
degree of rigor expected from such audits. One comment further 
suggested incorporating efforts by an international harmonization group 
known as the GHTF and its Study Groups I and IV in developing the 
format for reports. FDA officials, European government officials, and 
industry representatives are among those active in the GHTF, which is 
comprised of government and industry representatives from North 
America, Europe, Asia, and Australia, as well as observers from other 
countries and international organizations (see International 
Harmonization, Policy on Standards, in the Federal Register of October 
11, 1995 (60 FR 53081)).
    The comment also suggested that, in the interest of efficiency and 
to minimize translation costs, such reports should be in an abbreviated 
form in most circumstances. It further suggested that the reporting 
forms be limited to certification by the CAB that applicable 
requirements of the other party's regulations are met and that this 
certification may reference those documents which were examined to 
demonstrate compliance. The comment also recommended use of FDA's 
initiative known as the ``510(k) Paradigm'' that offers other ways of 
streamlining decisions on 510(k)'s.
    FDA expects to use relevant GHTF documents, as appropriate, in 
implementing the MRA. Study Group I of GHTF is developing a universal 
format which provides guidance on technical documentation with a view 
to first identifying similarities and divergences among various 
regulatory systems and then striving to achieve, to the extent 
possible, harmonization of requirements. At this time, this study group 
has reviewed requirements of existing systems and is now developing the 
essential principles which could facilitate harmonization of 
requirements, particularly as to premarket submissions. FDA is hopeful 
that it will be able to use guidance developed by Study Group I as 
guidance to MRA participants on the development of premarket evaluation 
reports.
    Study Group IV of GHTF is preparing guidelines for auditing quality 
systems of medical device manufacturers. These GHTF guidelines are now 
being made available for comments by principal participants in GHTF, 
e.g., by the EC United Kingdoms' Medical Devices Agency's Home Page and 
the United States through a future publication as a guidance in the  
Federal Register and in the FDA Home Page. FDA anticipates using audit 
guidance developed by Study Group IV in the implementation of the MRA.
    It is too soon to say precisely what formats will be used for 
premarket evaluation reports and quality system evaluation reports 
under the MRA. FDA intends to take into account the concerns expressed 
in the comment about minimizing the required documentation to that 
which is necessary. The formats for such reports will be developed 
during the MRA transition period, and FDA expects guidance from the 
GHTF study groups to be extremely helpful in this respect. During 
format development, FDA will work to develop formats that will not be 
unduly burdensome, so that forms and reports will include information 
sufficient for the parties to determine if normal endorsement is 
warranted. FDA will consider the use by third parties of FDA 
streamlining initiatives such as the 510(k) Paradigm in review of 
applications under the accredited persons program and the MRA. 
Information on the 510(k) paradigm can be accessed on the CDRH Home 
Page under ``Re-engineering Efforts'' (www.fda.gov/cdrh).
    12. Two comments raised the concern that the exchange of post 
market vigilance reports might create an administrative burden for 
industry if reports are not kept simple. One of the comments noted that 
industry has wanted to avoid multiple reporting and wishes to report 
only when there is a real and imminent danger to public health.
    FDA believes that adverse event reports need to be clear, concise, 
and

[[Page 60135]]

addressed to public health needs. FDA, through its participation in the 
GHTF Study Group II, is working toward a streamlined and harmonized 
system of reporting adverse events that are required by EC and U.S. 
laws and regulations. This effort is initially focused on harmonizing 
the guidelines for the types of adverse events that medical device 
manufacturers need to report. This guidance will make it easier for a 
manufacturer to decide which events need to be reported to the 
appropriate bodies in the EC and in the United States. The guidance 
developed by Study Group II will also be used to institute a mechanism 
for sharing adverse event data between the EC and United States under 
the MRA.
    13. Two comments expressed support for Sec. 26.48, 
``Harmonization,'' and one suggested that FDA should continue to 
participate in the efforts of the GHTF.
    FDA agrees with this comment and intends to continue to participate 
in these efforts, as resources allow.
    14. One comment suggested that the FDA consider provisions by which 
U.S. CAB's would perform domestic inspections under the act.
    This comment addresses issues outside of the scope of the MRA and 
of this rulemaking. Under the MRA and this regulation, U.S. CAB's will 
be designated only to conduct product type-examination and verification 
and/or quality system evaluations for products produced for export to 
the EC.
    15. One comment asked if the ``post market vigilance reports'' 
addressed under Sec. 26.33(a)(3) were the same as Medical Device 
Reports (MDR's).
    Post market vigilance reports and MDR's are similar mechanisms for 
reporting adverse incidents in the EC and the United States 
respectively. A system will be set up during the transition period and 
maintained thereafter by which the parties will notify each other when 
there is an immediate danger to public health. (See Sec. 26.50.) As 
part of the alert system, each party shall notify the other party of 
any confirmed problem reports, corrective actions, or recalls. The 
United States and EC plan to develop the data elements of such reports 
during the transition period, making use of draft documents already 
being prepared by the GHTF's Study Group II.
    16. One comment asked if the regulatory authorities mentioned in 
Sec. 26.34 and the designating authorities mentioned in Sec. 26.65 are 
the same.
    ``Regulatory Authority'' is defined in Sec. 26.60(a)(3) and 
``Designating Authority'' is defined in Sec. 26.60(a)(1) of the final 
rule. It is possible for these authorities to be different, or they may 
be the same. For the purpose of the Sectoral Annex on Medical Devices, 
regulatory authorities have the responsibility to implement the 
provisions of the Annex, including the designation and monitoring of 
CAB's.
    17. One comment asked if the criteria to be used by FDA to 
determine technical competence for product reviews is identical to that 
which is to be used in the U.S. third party program for accredited 
persons.
    The technical competence, qualifications, and freedom from conflict 
of interest for the product review (510(k)) part of the MRA are 
essentially the same as those being applied in FDA's third-party 
program for accredited persons. However, the MRA also includes quality 
systems audits, and CAB's performing quality systems audits under the 
MRA will need to have the additional training, expertise, and 
experience to perform quality systems audits. In this respect, the MRA 
is broader than the FDA third party accredited persons program.
    18. One comment supported Sec. 26.31, which states that the 
Sectoral Annex on Medical Devices should evolve and that the parties 
will periodically review the program to assess progress and identify 
enhancements. This comment also requested that timeframes be 
established for specific actions during the transition period. The 
comment also recommended that the regulatory authorities establish a 
schedule for the execution of the specified confidence building 
activities, under Sec. 26.35, that can serve to ``benchmark'' progress.
    FDA finds these comments extremely useful. Specific confidence 
building activities will depend on the nature of product evaluation and 
the extent of CAB utilization, and available resources. A process for 
scheduling confidence building activities and the schedule for 
accomplishing them will be developed by the United States and EC.
    19. One comment stressed the importance of defining the supporting 
evidence necessary to demonstrate the technical competence and 
independence of CAB's. This comment also requested that FDA make known 
to the general public the date and process by which the CAB's will be 
designated.
    FDA issued a Federal Register of July 2, 1998 (63 FR 36240) 
announcing the availability of a draft guidance entitled ``Draft 
Guidance for Staff, Industry, and Third Parties, Third Party Programs 
Under the Sectoral Annex on Medical Devices to the Agreement on Mutual 
Recognition between the United States of America and the European 
Community (MRA).'' This draft guidance addresses the criteria and 
qualifications expected to demonstrate technical competence and 
independence of CAB's. In addition, the draft guidance outlines the 
process for designation of CAB's under the Medical Devices Annex to the 
MRA. FDA will keep the public informed through the home page on the WWW 
of events under the MRA, such as designation of CAB's.
    20. One comment expressed concern that FDA stated that the 
operational period will start at the end of the transition period, and 
that FDA did not state that the transition period will be for a period 
of 3 years. The comment sought clarification.
    FDA disagrees that further clarification is needed. The duration of 
the Transition Period is 3 years. This is clearly stated in Sec. 26.35 
and in the Annex, Article 5.
    21. One comment supported the process of the importing party's 
regulatory authority routinely accepting or ``normally endorsing'' 
reports.
    FDA observes that this was the criterion agreed to in the Annex and 
stated in the regulation (Sec. 26.41(d), Exchange and endorsement of 
quality system reports, and Sec. 26.42(c), Exchange and endorsement of 
product evaluation reports).
    22. One comment sought clarification of the term ``normally 
endorse'' and expected that the importing party will endorse the vast 
majority of quality system evaluation and premarket evaluation reports.
    FDA anticipates that, once CAB's are designated, the importing 
party (FDA, in the case of devices to be imported into the United 
States) it is likely to endorse most reports. Sections 26.41(d) and 
26.42(c) describe the expectation that reports will normally be 
endorsed by the authority of the importing party, except under 
circumstances delineated in those provisions.
    23. One comment supported the need to continue to accept the 
results of conformity assessment procedures performed by a CAB prior to 
its suspension as a listed body, except in specified situations as 
identified in Sec. 26.67(f).
    FDA agrees with the comment's description of the Annex and the 
regulation but would also point out the provisions in the framework 
agreement and in Sec. 26.74 of this regulation allowing authorities on 
either side to take appropriate and immediate measures to protect 
public health.
    24. One comment expressed concern that the conformity assessment 
procedures performed by a CAB prior to

[[Page 60136]]

withdrawal remain valid subsequent to withdrawal.
    FDA notes that Sec. 26.68, ``Withdrawal of Listed Conformity 
Assessment Bodies,'' clearly delineates the circumstances under which a 
party is no longer required to accept or recognize results of 
conformity assessment procedures performed by CAB's (or, in the case of 
this Annex, to no long normally endorse reports provided by CAB's). As 
noted in the response in the preceding comment, however, nothing in the 
MRA or this regulation supersedes a participating country's ability to 
preclude shipments of products that present a concern under its laws. 
Whether there will be ``normal endorsement'' of assessments done by a 
CAB before its suspension or withdrawal would be determined, on the 
merits, based on the facts in the particular case (see, also, the 
discussion in comment 13 in section II.A of this document under the 
heading ``General Comments and Issues'')
    25. One comment suggested a definition section for subpart B.
    FDA does not believe that it is necessary to change the regulation 
to add a definition section. Guidance may be provided in the future, if 
necessary.
    26. One comment expected the list of CAB's would be published along 
with the final rule, or that the final rule would state when the list 
will be published.
    At this time, FDA is not certain of the date when the designation 
of CAB's will be made under the MRA. Once this occurs, however, the 
list will be made public on the FDA Home Page on the WWW.
    27. One comment requested availability of a description of the 
information which must be presented in quality system and premarket 
evaluation reports to be produced by CAB's. The comment suggested that 
this information is needed in order to judge the adequacy of the work 
of various CAB's.
    FDA agrees. The information that FDA expects to be present in 
quality system and product evaluation reports will be made public 
through the FDA Home Page on the WWW during the transition period. 
Comment 4 of the section II.F of this document describes how to obtain 
EC documents.
    28. One comment commented on the 90-day period provided for 
obtaining an inspection and requested provision for extension of this 
period for good cause.
    FDA realizes that the CAB's may not be able to accommodate all 
inspection requests within 60 or 90 days. Time extensions may be 
needed, for good cause, but FDA believes procedures for such a request 
need not be codified in this section.
    29. One comment strongly recommended that FDA conduct an on-going 
verification of the evaluation reports produced by the CAB's because 
they are vital to ensuring the safety and effectiveness of medical 
devices. This comment also raised concerns about the potential for 
conflicts of interest in a system of private review. (Some EC CAB's are 
private sector bodies.)
    FDA is sensitive to the concerns raised in this comment and 
recognizes the importance of adequate reports from CAB's regarding 
product evaluations and quality system evaluations as well as FDA's 
verifications. It is anticipated that FDA will rigorously evaluate both 
the reports and the CAB's that produce them. In addition, FDA has 
issued a notice announcing the availability of a draft guidance 
entitled ``Draft Guidance for Staff, Industry, and Third Parties, Third 
Party Programs Under the Sectoral Annex on Medical Devices to the 
Agreement on Mutual Recognition between the United States of America 
and the European Community (MRA),'' published in the Federal Register 
of July 2, 1998 (63 FR 36240). This document addresses conflict of 
interest concerns as well as technical competence criteria.
    Also, it should be kept in mind that final decisions on 510(k)'s 
will be made by FDA, ``normally endorsing'' submissions by CAB's, 
during both the transitional stage and the operational stage of the 
Medical Devices Annex.
    33. One comment suggested that the wording of Secs. 26.39(b) and 
26.46(b) be clarified. These sections address equivalence and listing 
of CAB's.
    FDA believes the wording of these sections is sufficiently clear. 
Further clarification, if necessary, could be considered in the future 
after experience is gained under these provisions.
    34. One comment stated that CAB's should be designated within the 
first 2 years of the transition period because sufficient accumulation 
of evidence supporting equivalence would be unlikely if designation 
occurred in the last year of the transition period.
    FDA points out that Article 6 of the Annex and Sec. 26.36 of this 
regulation states that ``each Party shall designate [CAB's] to 
participate in confidence-building activities by transmitting to the 
other Party a list of CAB's* * *.'' This transmission will be done at 
the start of the transition period. However, determinations of 
equivalence will be made following this exchange of lists and, indeed, 
will be a continuous feature of MRA implementation.
    35. One comment suggested that Sec. 26.37 be revised to include the 
frequency of workshops and seminars throughout the transitional and 
operational phases.
    FDA agrees that workshops and seminars are important. However, 
provisions for the frequency of workshops and seminars are not 
appropriate for inclusion in a rule. Furthermore, available resources 
will determine the frequency of joint training and seminars. FDA will 
continue to explore cost effective means, such as audio/video 
conferences and videotape training, to enhance the expertise of the CAB 
representatives. As stated earlier, an FDA training program for EC 
CAB's has been tentatively scheduled for October 14 to 16, 1998, in the 
Washington, DC area.
    36. One comment said that Sec. 26.46(c) implies that the 
designation of additional CAB's in the operational phase will occur 
only once each year. This comment went on to suggest that, if expansion 
of the CAB list is expected to be an annual event, then Sec. 26.66(b) 
should so state.
    FDA believes the language in Sec. 26.46(b) is sufficiently clear, 
and that there is no need for change in the regulatory provisions 
cited.
    37. One comment suggested that Sec. 26.65 be revised to state that, 
``Designating authorities shall only designate CAB's where the primary 
place of business is in the territory of the designating authority.''
    FDA disagrees with the suggestion, as it would introduce an 
unwarranted restriction into FDA's implementation of the MRA and this 
regulation. In any case, even if FDA were to adopt the comment's 
suggestion, the intended purpose of the suggested change could easily 
be overcome if a U.S. division of a foreign CAB simply formed a new 
corporation, under the law of a U.S. State, with the United States as 
the principal place of business.
    38. One comment noted that medical devices principally regulated by 
FDA's Center for Biologics Evaluation and Research (CBER) appear to 
have been excluded from the MRA.
    The comment is correct in noting that no CBER-regulated devices are 
included in the lists appended to the Sectoral Annex on Medical 
Devices. CBER has the lead responsibility for 510(k) review for 23 
medical device classifications. Adding some of these devices to the 
list of devices that FDA wishes to make eligible for review under the 
Annex, at this time, would require establishment of special handling 
procedures, training, and monitoring within CBER without the 
expectation of a meaningful number

[[Page 60137]]

of third party reviews. However, devices regulated by CBER under the 
device premarket notification provisions of the act (21 CFR 360(k)) 
might be considered for eligibility in the MRA program as experience 
and confidence develops.
    39. A comment addressed issues of grammar and format and did not 
deal with substantive matters relevant to the MRA that would have any 
bearing on its content, issues, or outcome.
    FDA declines to alter the text of the proposed rule in response to 
this comment. Throughout this rulemaking process FDA has attempted to 
adhere to the language contained in the MRA unless serious substantive 
matters were identified having bearing on the content, issues, or 
outcome of the MRA or this regulation. The nonsubstantive issues raised 
by this comment do not justify any amendments to this regulation.

III. Summary of Changes

    1. In response to a comment, the title of the proposed regulation 
has been changed to the following: ``Part 26--Mutual Recognition of 
Pharmaceutical Good Manufacturing Practice Reports, Medical Device 
Quality System Audit Reports, and Certain Medical Device Product 
Evaluation Reports: the United States and the European Community.''
    2. On its own initiative, FDA has determined that the language of 
proposed Sec. 26.0 should be amended to provide additional and more 
precise explanation about the applicability of this regulation with 
regard to other U.S. agencies and the EC. Therefore, proposed Sec. 26.0 
has been amended to read as follows:

Section 26.0 General.

    This part substantially reflects relevant provisions of the 
framework agreement and its sectoral annexes on pharmaceutical good 
manufacturing practices (GMP's) and medical devices entitled 
``Agreement on Mutual Recognition Between the United States of 
America and the European Community'' (the MRA), signed in London on 
May 18, 1998. For codification purposes, certain provisions of the 
MRA have been modified for use in this part. This modification is 
done for purposes of clarity only and shall not affect the text of 
the MRA concluded between the United States and the European 
Community (EC), or the rights and obligations of the United States 
or the EC under that agreement. Whereas the parties to the MRA are 
the United States and the European Community (EC), this part is 
relevant only to the Food and Drug Administration's (FDA's) 
implementation of the MRA, including the sectoral annexes reflected 
in subparts A and B of this part. This part does not govern 
implementation of the MRA by the EC, which will implement the MRA in 
accordance with its internal procedures, nor does this part address 
implementation of the MRA by other concerned U.S. Federal agencies. 
For purposes of this part, the terms ``party'' or ``parties,'' where 
relevant to FDA's implementation of the MRA, should be considered as 
referring to FDA only. If the parties to the MRA subsequently amend 
or terminate the MRA, FDA will modify this part accordingly, using 
appropriate administrative procedures.
    3. On its own initiative FDA has amended several sections of the 
proposed rule to more accurately describe the relationship between the 
provisions of this part and the provisions of the MRA. Specifically, 
Secs. 26.6(d), 26.61, 26.73, 26.78, 26.79, and 26.81(d) have been 
appropriately changed to accomplish this purpose.
    4. In response to one comment, Table 1 of the proposed rule 
concerning the product code for radiographic screens, Sec. 892.1960, is 
amended in the final rule to reflect the correction of a typographical 
error: ``WAM'' is changed to read ``EAM.''
    5. Other typographical errors and nonsubstantive changes in the MRA 
have been identified by FDA and the EC since the FDA proposed rule was 
published on April 10, 1998. Because FDA has endeavored to have this 
regulation reflect the text of the MRA as accurately as possible, the 
final rule has been amended to reflect all of these nonsubstantive 
changes. For example, in Sec. 26.4, the reference is now ``European 
Community (EC), rather than ``European Union'' or ``EU,'' in accordance 
with the preference of the EC. The EC is the correct entity, as the EU 
is not a juridical entity.
    6. The agency has amended the authority citation to refer to U.S. 
statutes on confidentiality (5 U.S.C. 552, 18 U.S.C. 1905, and 21 
U.S.C. 331) as well as the new accredited persons provisions of the act 
(section 523, 21 U.S.C. 360m) added by FDAMA.
    7. Under Appendix E of Subpart A (Elements to be Considered in 
Developing a Two-Way Alert System), for administrative reasons the 
contact points for FDA are changed from ``FDA's Division of Emergency 
and Investigational Operations'' to the following:
    Biologics: Director, Office of Compliance and Biologics Quality 
(HFM-600), 1401 Rockville Pike, Rockville, MD 20852, phone: 301-827-
6190, fax: 301-594-1944.
    Human Drugs: Director, Office of Compliance (HFD-300), MPN I, 
7520 Standish Pl., Rockville, MD 20855-2737, phone: 301-594-0054, 
fax: 301-594-2114.
    Veterinary Drugs: Director, Office of Surveillance and 
Compliance (HFV-200), MPN II, 7500 Standish Pl., Rockville, MD 
20855-2773, phone: 301-827-6644, fax: 301-594-1807.
    8. Under Sec. 26.1(c), the definition of Good Manufacturing 
Practices (GMP's) has been changed from the following:
    (c) Good Manufacturing Practices (GMP's): [These GMP conceptual 
definitions are to be merged by the parties at a future date.]
    (1) GMP's mean the requirements found in the respective 
legislations, regulations, and administrative provisions for methods 
to be used in, and the facilities or controls to be used for, the 
manufacturing, processing, packing, and/or holding of a drug to 
assure that such drug meets the requirements as to safety, and has 
the identity and strength, and meets the quality and purity 
characteristics that it purports or is represented to possess.
    (2) GMP's are that part of quality assurance which ensures that 
products are consistently produced and controlled to quality 
standards. For the purpose of this subpart, GMP's include, 
therefore, the system whereby the manufacturer receives the 
specifications of the product and/or process from the marketing 
authorization/product authorization or license holder or applicant 
and ensures the product is made in compliance with its 
specifications (qualified person certification in the European 
Community (EC)).
to the following:
    (c)  Good Manufacturing Practices (GMP's): [The United States 
has clarified its interpretation that under the MRA, that only 
paragraph (c)(1) of this section has to be understood as the U.S. 
definition and paragraph (c)(2) as the EC definition.]
    (1) GMP's mean the requirements found in the legislations, 
regulations, and administrative provisions for methods to be used 
in, and the facilities or controls to be used for, the 
manufacturing, processing, packing, and/or holding of a drug to 
assure that such drug meets the requirements as to safety, and has 
the identity and strength, and meets the quality and purity 
characteristics that it purports or is represented to possess.
    (2) GMP's are that part of quality assurance which ensures that 
products are consistently produced and controlled to quality 
standards. For the purpose of this subpart, GMP's include, 
therefore, the system whereby the manufacturer receives the 
specifications of the product and/or process from the marketing 
authorization/product authorization or license holder or applicant 
and ensures the product is made in compliance with its 
specifications (qualified person certification in the EC).
    The previous changes reflect discussions between FDA and European 
Commission officials. As a result of those discussions, the United 
States has clarified its interpretation that the first paragraph of 
Article 1(3) of the Sectoral Annex for Pharmaceutical GMP's, has to be 
understood as the U.S. definition and the second as the EC definition. 
The agency believes that these changes are appropriate because they 
clarify that the applicable definition under the MRA

[[Page 60138]]

will be consistent with the act and regulations (see, e.g., section 
501(a)(2)(B) of the act; 21 U.S.C. 351(a)(2)(B)). Furthermore, the 
Sectoral Annex on Pharmaceutical GMP's, including its core concept of 
``equivalence,'' does not require either party to change its definition 
or application of GMP's.
    9. Changes have been made to the list of regulatory authorities 
contained in Appendix B of Subpart A (List of Authorities) as a result 
of the legal review carried out in the EC prior to finalizing the MRA. 
The European Commission amended its list of regulatory authorities 
contained in Appendix 2 of the Pharmaceutical GMP Annex of the MRA 
because the changes more correctly reflect the allocation of 
administrative competencies in the EC and its Member States and do not 
alter the activities to be carried out under the MRA.
    10. Changes have been made to Table 2. of Appendix B of Subpart B 
of the rule. That table listed 42 class II medical devices to be 
included within the scope of product coverage at the beginning of the 
transition period. Four of the devices that were on the list cannot be 
reviewed by conformity assessment bodies under the MRA and this rule, 
because of a statutory prohibition in the act. Accordingly, the 
agreement will be brought into force without application to those four 
devices. Section 523 of the act prohibits ``accredited persons'' from 
performing review of a class II device that is intended to be 
permanently implantable, life sustaining, or life supporting, and 
review of such devices must be performed by FDA. This provision was 
recently added to the act by FDAMA. The agency recently determined that 
the following four devices are within the scope of the prohibition and 
have been removed from Table 2: AN 868.5925, powered emergency 
ventilator; OR 888.3020, intramedullary fixation rod; OR 888.3030, 
single/multiple component metallic bone fixation appliances and 
accessories; and OR 888.3040, smooth or threaded metallic bone fixation 
fastener. The United States has informed the EC of this situation and 
of the need to make appropriate amendments to the MRA promptly after 
its entry into force.

IV. Analysis of Impacts

     FDA has examined the impacts of the final rule under Executive 
Order 12866, under the Regulatory Flexibility Act (Pub. L. 96-354, as 
amended by Pub. L. 104-121), and under the Unfunded Mandates Reform Act 
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant economic impact 
of a rule on a substantial number of small entities. The Unfunded 
Mandates Reform Act requires agencies to prepare an assessment of 
anticipated costs and benefits before enacting any rule that may result 
in an expenditure by State, local and tribal governments, in the 
aggregate, or by the private sector, of $100 million (adjusted annually 
for inflation) in any 1 year.
     The agency believes that this final rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order 
and in these two statutes. Through this regulation, the agency sets out 
requirements through which it may normally endorse certain conformity 
assessment procedure reports. Such reports would be provided by 
equivalent EC Member State regulatory authorities for manufacturing 
site inspections to ascertain conformity with pharmaceutical GMP's and 
by equivalent CAB's for quality system audits and certain medical 
device premarket evaluations. Obtaining conformity assessment 
information in the manner described in the final rule is more efficient 
and cost-effective than the existing approach, where additional 
inspection efforts by FDA in foreign countries are necessary because 
foreign regulatory systems have not been found equivalent. The primary 
benefit of the final rule is to provide credible assurance that the 
increasing volume of EC Member States' imports into the United States 
meet pharmaceutical GMP requirements, and medical device quality system 
evaluation and certain premarket evaluation requirements, as specified 
in U.S. statutes and regulations. In the future, this credible 
assurance must be achievable with FDA resource expenditures that rise 
less than proportionately to the volume of trade.
     In recent years, the credibility of the current approach has been 
strained as FDA's essentially constant foreign inspection capacity has 
been stretched over an expanding volume of imports from the EC. In the 
3-year interval between 1994 and 1997, the value of EC pharmaceutical 
and medical device imports into the United States has nearly doubled 
from $5.5 billion to more than $10.7 billion. Growth has been greatest 
in pharmaceuticals, where annual EC exports have increased by more than 
$2 billion in each of the last 2 years. In 1997, FDA conducted one 
inspection in the EC for every $60 million in pharmaceutical exports to 
the United States, which is less than half the coverage intensity of 
1994. In addition, the majority of these inspections have been 
preapproval in nature. Continuation of the current trend would further 
decrease FDA's coverage intensity to less than one inspection per $100 
million in EC pharmaceutical exports by the year 2000. Equivalence with 
EC Member State regulatory systems would leverage FDA's regulatory 
resources so that necessary conformity assessments can be ensured 
despite higher volumes of future trade.
     In addition to helping FDA cope with higher trade volumes, mutual 
recognition or equivalence-based agreements with exporting nations may 
permit FDA to redirect some of its inspectional resources to risk 
priorities not covered by such agreements. This flexibility would 
provide a more responsive level of U.S. consumer protection in the face 
of a changing global marketplace with inherently variable risk 
management priorities.
     Another important benefit of the final rule would be the cost 
savings realized by the regulated industry, largely as a result of the 
sharing of inspection reports among equivalent regulatory authorities. 
This exchange, in turn, will minimize the need for duplicative 
inspections and permit individual firms to undergo fewer inspections of 
manufacturing sites. FDA does not have data on the average 
administrative cost incurred by manufacturers of pharmaceuticals 
(including biologicals) or medical devices as they participate in 
regulatory inspections, but it is likely that the avoidance of 
redundant inspections would generate cost savings. The final rule also 
may shorten product review times for regulated products as a result of 
the increased efficiency of premarket approval inspection activities 
and the third-party evaluation of certain medical devices. 
Quantification of these savings will be highly dependent on the 
specific countries that achieve equivalence and on the number of 
medical device audits and evaluations performed by CAB's under the MRA.
     The costs of this regulation will have a greater impact on 
governmental regulatory agencies than on the regulated industry. These 
governmental costs involve both startup and operational components. FDA 
has not received additional government funding earmarked for achieving 
mutual

[[Page 60139]]

recognition agreements and, therefore, must proceed to implement these 
agreements as a concurrent function within normal day-to-day regulatory 
activities. The 3-year transition period reflects the necessity to 
absorb these startup costs within existing regulatory budgets. Some 
activities such as joint inspections may be reasonably easy to absorb 
as concurrent functions that do not require additional funding, while 
others such as developing and maintaining systems for routine 
information exchange may involve new activities. These absorbed 
governmental costs will fall heavily on FDA, as it must assess 
equivalence of multiple EC Member States and notified bodies.
     For FDA, the absorption of these startup costs will be easier with 
respect to those EC Member States with which the United States already 
has a large volume of trade in the products in question, where FDA 
already conducts enough inspections to have gathered a general 
understanding of the requirements and regulatory practices of the 
exporting country. From this perspective, the pace and priorities for 
mutual recognition agreements during the transition period will be 
affected by FDA's ability to conduct these processes as concurrent 
functions within current activities.
     In the longer run, an operational system of mutual recognition 
agreements could pose additional costs or problems for regulatory 
authorities of exporting countries if equivalence requires a frequency, 
focus or content of inspections not presently included in regulatory 
requirements of the exporting nation. For example, Country A may not be 
able to provide the frequency of medical device inspections desired by 
Country B without conducting inspections beyond those required for 
Country A's domestic inspection strategy. Conversely, Country B may not 
be able to provide to Country A adequate details of the quality of 
pharmaceutical source materials, because Country B does not have 
inspectional authority over pharmaceutical starting materials. To the 
extent that such costs or problems are insignificant or offset by other 
savings, they will not be obstacles to reaching agreement on 
equivalence.
     This rule is not expected to involve any new incremental costs to 
the affected industries. Although joint inspections during the 
transition period may create the appearance of more regulatory effort, 
they would not impose additional costs on the firms inspected. FDA does 
not anticipate an increase in the total number of EC inspections, and 
in fact, the coverage intensity of FDA inspections in the EC would be 
expected to continue to fall during the transition period, as it has 
for the past several years. Other activities related to equivalence 
determinations, such as the procedures for exchanging information and 
reports, focus on the interface and coordination among regulatory 
agencies and, as such, will not affect industry in a cost context.
     The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities unless the rule is not expected to have a significant 
economic impact on a substantial number of small entities. As this 
final regulation is not expected to impose costs on the regulated 
industry, and FDA has received no comments that would indicate 
otherwise, the agency certifies that this rule will not have a 
significant impact on a substantial number of small entities. 
Therefore, under the Regulatory Flexibility Act, no further analysis is 
required.
     The Unfunded Mandates Act of 1995 requires that agencies prepare 
an assessment of the anticipated costs and benefits before issuing any 
final rule that may result in expenditures by State, local, and tribal 
governments, in the aggregate, or by the private sector, of $100 
million or more (adjusted annually for inflation) in any 1 year. This 
rule does not impose any mandates on State, local or tribal 
governments, or the private sector that would result in an annual 
expenditure of $100 million or more. Therefore, no further analysis is 
appropriate for this requirement.

V. Paperwork Reduction Act of 1995

     This final rule does not contain any information collection 
provisions that would be subject to review by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520).

VI. References

    1. The 1992 ``Report of the Task Force on International 
Harmonization'' is available from the National Technical Information 
Service, Vienna, VA; Order # PB93128155.
    2. FDA's Compliance Policy Guides ``Sec. 100.900, International 
Memoranda of Understanding (CPG 7150.19)'' is available from the 
National Technical Information Service, Vienna, VA 22161 (Order # PB 
96-915499INZ) or can be found on FDA's website at the following 
location: ``www.fda.gov/ora/compliance__ref/cpg/
cpgch1.htm#sec.100.900''.
    3. The 1997 ``Summary Report of the Foreign Inspection Working 
Group'' is available from the Freedom of Information Staff (HFI-35), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857.

VII. Comparison Table

     The following table shows the relationship of the MRA Articles and 
the sections of the Code of Federal Regulations (CFR) under this rule:

   Table 1.-- Relationship of the MRA Articles to sections in the CFR
------------------------------------------------------------------------
              MRA Article                          CFR Section
------------------------------------------------------------------------
Sectoral Annex for Pharmaceutical GMP's              Subpart A
------------------------------------------------------------------------
Article 1..............................   26.1
Article 2..............................   26.2
Article 3..............................  26.3
Article 4..............................  26.4
Article 5..............................  26.5
Article 6..............................  26.6
Article 7..............................  26.7
Article 8..............................  26.8
Article 9..............................  26.9
Article 10.............................  26.10
Article 11.............................   26.11
Article 12.............................   26.12
Article 13.............................   26.13
Article 14.............................  26.14
Article 15.............................  26.15

[[Page 60140]]

Article 16.............................  26.16
Article 17.............................  26.17
Article 18.............................   26.18
Article 19.............................  26.19
Article 20.............................  26.20
Article 21.............................  26.21
Appendix 1.............................  Appendix A
Appendix 2.............................   Appendix B
Appendix 3.............................  Appendix C
Appendix 4.............................  Appendix D
Appendix 5.............................  Appendix E
------------------------------------------------------------------------


------------------------------------------------------------------------
              MRA Article                          CFR Section
------------------------------------------------------------------------
   Sectoral Annex on Medical Devices                Subpart B
------------------------------------------------------------------------
Article 1..............................  26.31
Article 2..............................  26.32
Article 3..............................  26.33
Article 4..............................  26.34
Article 5..............................  26.35
Article 6..............................  26.36
Article 7..............................  26.37
Article 8..............................  26.38
Article 9..............................  26.39
Article 10.............................  26.40
Article 11.............................  26.41
Article 12.............................  26.42
Article 13.............................  26.43
Article 14.............................  26.44
Article 15.............................  26.45
Article 16.............................  26.46
Article 17.............................  26.47
Article 18.............................  26.48
Article 19.............................  26.49
Article 20.............................  26.50
Appendix 1.............................   Appendix A
Appendix 2 and Tables 1-3..............  Appendix B and Tables 1-3
Appendix 3 [Reserved]..................  Appendix C [Reserved]
Appendix 4 [Reserved]..................  Appendix D [Reserved]
Appendix 5 [Reserved]..................  Appendix E [Reserved]
Appendix 6 [Reserved]..................  Appendix F [Reserved]
------------------------------------------------------------------------


------------------------------------------------------------------------
              MRA Article                          CFR Section
------------------------------------------------------------------------
          Framework Agreement                       Subpart C
------------------------------------------------------------------------
Article 1..............................  26.60
Article 2..............................  26.61
Article 3..............................  26.62
Article 4..............................  26.63
Article 5..............................  26.64
Article 6..............................  26.65
Article 7..............................  26.66
Article 8..............................  26.67
Article 9..............................  26.68
Article 10.............................  26.69
Article 11.............................   26.70
Article 12.............................   26.71
Article 13.............................  26.72
Article 14.............................  26.73
Article 15.............................  26.74
Article 16.............................  26.75
Article 17.............................  26.76
Article 18.............................  26.77

[[Page 60141]]

Article 19.............................  26.78
Article 20.............................  26.79
Article 21.............................  26.80
Article 22.............................   26.81
------------------------------------------------------------------------

List of Subjects in 21 CFR Part 26

    Animal and human drugs, Biologicals, Devices, Exports, Imports, 
Incorporation by reference, and Inspections.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and the 
Public Health Service Act and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR chapter I is amended by adding 
part 26 to read as follows:

PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING 
PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND 
CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES 
AND THE EUROPEAN COMMUNITY

Sec.
26.0 General.

Subpart A--Specific Sector Provisions for Pharmaceutical Good 
Manufacturing Practices

26.1   Definitions.
26.2   Purpose.
26.3   Scope.
26.4   Product coverage.
26.5   Length of transition period.
26.6   Equivalence assessment.
26.7   Participation in the equivalence assessment and 
determination.
26.8   Other transition activities.
26.9   Equivalence determination.
26.10   Regulatory authorities not listed as currently equivalent.
26.11   Start of operational period.
26.12   Nature of recognition of inspection reports.
26.13   Transmission of postapproval inspection reports.
26.14   Transmission of preapproval inspection reports.
26.15   Monitoring continued equivalence.
26.16   Suspension.
26.17   Role and composition of the Joint Sectoral Committee.
26.18   Regulatory collaboration.
26.19   Information relating to quality aspects.
26.20   Alert system.
26.21   Safeguard clause.
Appendix A of Subpart A--List of Applicable Laws, Regulations, and 
Administrative Provisions.
Appendix B of Subpart A--List of Authorities.
Appendix C of Subpart A--Indicative List of Products Covered by 
Subpart A.
Appendix D of Subpart A--Criteria for Assessing Equivalence for 
Post- and Preapproval.
Appendix E of Subpart A--Elements to be Considered in Developing a 
Two-Way Alert System.

Subpart B--Specific Sector Provisions for Medical Devices

26.31   Purpose.
26.32   Scope.
26.33   Product coverage.
26.34   Regulatory authorities.
26.35   Length and purpose of transition period.
26.36   Listing of CAB's.
26.37   Confidence building activities.
26.38   Other transition period activities.
26.39   Equivalence assessment.
26.40   Start of the operational period.
26.41   Exchange and endorsement of quality system evaluation 
reports.
26.42   Exchange and endorsement of product evaluation reports.
26.43   Transmission of quality system evaluation reports.
26.44   Transmission of product evaluation reports.
26.45   Monitoring continued equivalence.
26.46   Listing of additional CAB's.
26.47   Role and composition of the Joint Sectoral Committee.
26.48   Harmonization.
26.49   Regulatory cooperation.
26.50   Alert system and exchange of postmarket vigilance reports.
Appendix A of Subpart B--Relevant Legislation, Regulations, and 
Procedures.
Appendix B of Subpart B--Scope of Product Coverage.
Appendix C of Subpart B [Reserved].
Appendix D of Subpart B [Reserved].
Appendix E of Subpart B [Reserved].
Appendix F of Subpart B [Reserved].

Subpart C--``Framework'' Provisions

26.60   Definitions.
26.61   Purpose of this part.
26.62   General obligations.
26.63   General coverage of this part.
26.64   Transitional arrangements.
26.65   Designating authorities.
26.66   Designation and listing procedures.
26.67   Suspension of listed conformity assessment bodies.
26.68   Withdrawal of listed conformity assessment bodies.
26.69   Monitoring of conformity assessment bodies.
26.70   Conformity assessment bodies.
26.71   Exchange of information.
26.72   Sectoral contact points.
26.73   Joint Committee.
26.74   Preservation of regulatory authority.
26.75   Suspension of recognition obligations.
26.76   Confidentiality.
26.77   Fees.
26.78   Agreements with other countries.
26.79   Territorial application.
26.80   Entry into force, amendment, and termination.
26.81   Final provisions.
     Authority:  5 U.S.C. 552; 15 U.S.C. 1453, 1454, 1455; 18 U.S.C. 
1905; 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 360c, 360d, 
360e, 360f, 360g, 360h, 360i, 360j, 360l, 360m, 371, 374, 381, 382, 
383, 393; 42 U.S.C. 216, 241, 242l, 262, 264, 265.


Sec. 26.0   General.

     This part substantially reflects relevant provisions of the 
framework agreement and its sectoral annexes on pharmaceutical good 
manufacturing practices (GMP's) and medical devices of the ``Agreement 
on Mutual Recognition Between the United States of America and the 
European Community'' (the MRA), signed at London May 18, 1998. For 
codification purposes, certain provisions of the MRA have been modified 
for use in this part. This modification is done for purposes of clarity 
only and shall not affect the text of the MRA concluded between the 
United States and the European Community (EC), or the rights and 
obligations of the United States or the EC under that agreement. 
Whereas the parties to the MRA are the United States and EC, this part 
is relevant only to the Food and Drug Administration's (FDA's) 
implementation of the MRA, including the sectoral annexes reflected in 
subparts A and B of this part. This part does not govern implementation 
of the MRA by the EC, which will implement the MRA in accordance with 
its internal procedures, nor does this part address implementation of 
the MRA by other concerned U.S. Federal agencies. For purposes of this 
part, the terms ``party'' or ``parties,'' where relevant to FDA's 
implementation of the MRA, should be considered as referring to FDA 
only. If the parties to the MRA subsequently amend or terminate the 
MRA, FDA will modify this part accordingly, using appropriate 
administrative procedures.

[[Page 60142]]

Subpart A--Specific Sector Provisions for Pharmaceutical Good 
Manufacturing Practices


Sec. 26.1   Definitions.

     (a) Enforcement means action taken by an authority to protect the 
public from products of suspect quality, safety, and effectiveness or 
to assure that products are manufactured in compliance with appropriate 
laws, regulations, standards, and commitments made as part of the 
approval to market a product.
     (b) Equivalence of the regulatory systems means that the systems 
are sufficiently comparable to assure that the process of inspection 
and the ensuing inspection reports will provide adequate information to 
determine whether respective statutory and regulatory requirements of 
the authorities have been fulfilled. Equivalence does not require that 
the respective regulatory systems have identical procedures.
    (c) Good Manufacturing Practices (GMP's). [The United States has 
clarified its interpretation that under the MRA, that only paragraph 
(c)(1) of this section has to be understood as the U.S. definition and 
paragraph (c)(2) as the EC definition.]
    (1) GMP's mean the requirements found in the legislations, 
regulations, and administrative provisions for methods to be used in, 
and the facilities or controls to be used for, the manufacturing, 
processing, packing, and/or holding of a drug to assure that such drug 
meets the requirements as to safety, and has the identity and strength, 
and meets the quality and purity characteristics that it purports or is 
represented to possess.
    (2) GMP's are that part of quality assurance which ensures that 
products are consistently produced and controlled to quality standards. 
For the purpose of this subpart, GMP's include, therefore, the system 
whereby the manufacturer receives the specifications of the product 
and/or process from the marketing authorization/product authorization 
or license holder or applicant and ensures the product is made in 
compliance with its specifications (qualified person certification in 
the EC).
    (d) Inspection means an onsite evaluation of a manufacturing 
facility to determine whether such manufacturing facility is operating 
in compliance with GMP's and/or commitments made as part of the 
approval to market a product.
     (e) Inspection report means the written observations and GMP's 
compliance assessment completed by an authority listed in Appendix B of 
this subpart.
     (f) Regulatory system means the body of legal requirements for 
GMP's, inspections, and enforcements that ensure public health 
protection and legal authority to assure adherence to these 
requirements.


Sec. 26.2   Purpose.

     The provisions of this subpart govern the exchange between the 
parties and normal endorsement by the receiving regulatory authority of 
official good manufacturing practices (GMP's) inspection reports after 
a transitional period aimed at determination of the equivalence of the 
regulatory systems of the parties, which is the cornerstone of this 
subpart.


Sec. 26.3   Scope.

     (a) The provisions of this subpart shall apply to pharmaceutical 
inspections carried out in the United States and Member States of the 
European Community (EC) before products are marketed (hereafter 
referred to as ``preapproval inspections'') as well as during their 
marketing (hereafter referred to as ``postapproval inspections'').
     (b) Appendix A of this subpart names the laws, regulations, and 
administrative provisions governing these inspections and the good 
manufacturing practices (GMP's) requirements.
     (c) Appendix B of this subpart lists the authorities participating 
in activities under this subpart.
     (d) Sections 26.65, 26.66, 26.67, 26.68, 26.69, and 26.70 of 
subpart C of this part do not apply to this subpart.


Sec. 26.4   Product coverage.

     (a) The provisions of this subpart will apply to medicinal 
products for human or animal use, intermediates and starting materials 
(as referred to in the European Community (EC)) and to drugs for human 
or animal use, biological products for human use, and active 
pharmaceutical ingredients (as referred to in the United States), only 
to the extent they are regulated by the authorities of both parties as 
listed in Appendix B of this subpart.
     (b) Human blood, human plasma, human tissues and organs, and 
veterinary immunologicals (under 9 CFR 101.2, ``veterinary 
immunologicals'' are referred to as ``veterinary biologicals'') are 
excluded from the scope of this subpart. Human plasma derivatives (such 
as immunoglobulins and albumin), investigational medicinal products/new 
drugs, human radiopharmaceuticals, and medicinal gases are also 
excluded during the transition phase; their situation will be 
reconsidered at the end of the transition period. Products regulated by 
the Food and Drug Administration's Center for Biologics Evaluation and 
Research as devices are not covered under this subpart.
     (c) Appendix C of this subpart contains an indicative list of 
products covered by this subpart.


Sec. 26.5   Length of transition period.

     A 3-year transition period will start immediately after the 
effective date described in Sec. 26.80(a).


Sec. 26.6   Equivalence assessment.

     (a) The criteria to be used by the parties to assess equivalence 
are listed in Appendix D of this subpart. Information pertaining to the 
criteria under European Community (EC) competence will be provided by 
the EC.
     (b) The authorities of the parties will establish and communicate 
to each other their draft programs for assessing the equivalence of the 
respective regulatory systems in terms of quality assurance of the 
products and consumer protection. These programs will be carried out, 
as deemed necessary by the regulatory authorities, for post- and 
preapproval inspections and for various product classes or processes.
     (c) The equivalence assessment shall include information exchanges 
(including inspection reports), joint training, and joint inspections 
for the purpose of assessing regulatory systems and the authorities' 
capabilities. In conducting the equivalence assessment, the parties 
will ensure that efforts are made to save resources.
     (d) Equivalence assessment for authorities added to Appendix B of 
this subpart after the effective date described in Sec. 26.80(a) will 
be conducted as described in this subpart, as soon as practicable.


Sec. 26.7   Participation in the equivalence assessment and 
determination.

     The authorities listed in Appendix B of this subpart will actively 
participate in these programs to build a sufficient body of evidence 
for their equivalence determination. Both parties will exercise good 
faith efforts to complete equivalence assessment as expeditiously as 
possible to the extent the resources of the authorities allow.


Sec. 26.8   Other transition activities.

     As soon as possible, the authorities will jointly determine the 
essential information which must be present in inspection reports and 
will cooperate to develop mutually agreed inspection report format(s).

[[Page 60143]]

Sec. 26.9   Equivalence determination.

     (a) Equivalence is established by having in place regulatory 
systems covering the criteria referred to in Appendix D of this 
subpart, and a demonstrated pattern of consistent performance in 
accordance with these criteria. A list of authorities determined as 
equivalent shall be agreed to by the Joint Sectoral Committee at the 
end of the transition period, with reference to any limitation in terms 
of inspection type (e.g., postapproval or preapproval) or product 
classes or processes.
     (b) The parties will document insufficient evidence of 
equivalence, lack of opportunity to assess equivalence or a 
determination of nonequivalence, in sufficient detail to allow the 
authority being assessed to know how to attain equivalence.


Sec. 26.10   Regulatory authorities not listed as currently equivalent.

     Authorities not currently listed as equivalent, or not equivalent 
for certain types of inspections, product classes or processes may 
apply for reconsideration of their status once the necessary corrective 
measures have been taken or additional experience is gained.


Sec. 26.11   Start of operational period.

     (a) The operational period shall start at the end of the 
transition period and its provisions apply to inspection reports 
generated by authorities listed as equivalent for the inspections 
performed in their territory.
     (b) In addition, when an authority is not listed as equivalent 
based on adequate experience gained during the transition period, the 
Food and Drug Administration (FDA) will accept for normal endorsement 
(as provided in Sec. 26.12) inspection reports generated as a result of 
inspections conducted jointly by that authority on its territory and 
another authority listed as equivalent, provided that the authority of 
the Member State in which the inspection is performed can guarantee 
enforcement of the findings of the inspection report and require that 
corrective measures be taken when necessary. FDA has the option to 
participate in these inspections, and based on experience gained during 
the transition period, the parties will agree on procedures for 
exercising this option.
     (c) In the European Community (EC), the qualified person will be 
relieved of responsibility for carrying the controls laid down in 
Article 22 paragraph 1(b) of Council Directive 75/319/EEC (see Appendix 
A of this subpart) provided that these controls have been carried out 
in the United States and that each batch/lot is accompanied by a batch 
certificate (in accordance with the World Health Organization 
Certification Scheme on the Quality of Medicinal Products) issued by 
the manufacturer certifying that the product complies with requirements 
of the marketing authorization and signed by the person responsible for 
releasing the batch/lot.


Sec. 26.12 Nature of recognition of inspection reports.

     (a) Inspection reports (containing information as established 
under Sec. 26.8), including a good manufacturing practice (GMP) 
compliance assessment, prepared by authorities listed as equivalent, 
will be provided to the authority of the importing party. Based on the 
determination of equivalence in light of the experience gained, these 
inspection reports will normally be endorsed by the authority of the 
importing party, except under specific and delineated circumstances. 
Examples of such circumstances include indications of material 
inconsistencies or inadequacies in an inspection report, quality 
defects identified in the postmarket surveillance or other specific 
evidence of serious concern in relation to product quality or consumer 
safety. In such cases, the authority of the importing party may request 
clarification from the authority of the exporting party which may lead 
to a request for reinspection. The authorities will endeavor to respond 
to requests for clarification in a timely manner.
     (b) Where divergence is not clarified in this process, an 
authority of the importing country may carry out an inspection of the 
production facility.


Sec. 26.13   Transmission of postapproval inspection reports.

     Postapproval good manufacturing practice (GMP) inspection reports 
concerning products covered by this subpart will be transmitted to the 
authority of the importing country within 60-calendar days of the 
request. Should a new inspection be needed, the inspection report will 
be transmitted within 90-calendar days of the request.


Sec. 26.14   Transmission of preapproval inspection reports.

     (a) A preliminary notification that an inspection may have to take 
place will be made as soon as possible.
     (b) Within 15-calendar days, the relevant authority will 
acknowledge receipt of the request and confirm its ability to carry out 
the inspection. In the European Community (EC), requests will be sent 
directly to the relevant authority, with a copy to the European Agency 
for the Evaluation of Medicinal Products (EMEA). If the authority 
receiving the request cannot carry out the inspection as requested, the 
requesting authority shall have the right to conduct the inspection.
     (c) Reports of preapproval inspections will be sent within 45-
calendar days of the request that transmitted the appropriate 
information and detailed the precise issues to be addressed during the 
inspection. A shorter time may be necessary in exceptional cases and 
these will be described in the request.


Sec. 26.15   Monitoring continued equivalence.

     Monitoring activities for the purpose of maintaining equivalence 
shall include review of the exchange of inspection reports and their 
quality and timeliness; performance of a limited number of joint 
inspections; and the conduct of common training sessions.


Sec. 26.16   Suspension.

     (a) Each party has the right to contest the equivalence of a 
regulatory authority. This right will be exercised in an objective and 
reasoned manner in writing to the other party.
     (b) The issue shall be discussed in the Joint Sectoral Committee 
promptly upon such notification. Where the Joint Sectoral Committee 
determines that verification of equivalence is required, it may be 
carried out jointly by the parties in a timely manner, under Sec. 26.6.
     (c) Efforts will be made by the Joint Sectoral Committee to reach 
unanimous consent on the appropriate action. If agreement to suspend is 
reached in the Joint Sectoral Committee, an authority may be suspended 
immediately thereafter. If no agreement is reached in the Joint 
Sectoral Committee, the matter is referred to the Joint Committee as 
described in Sec. 26.73. If no unanimous consent is reached within 30 
days after such notification, the contested authority will be 
suspended.
     (d) Upon the suspension of authority previously listed as 
equivalent, a party is no longer obligated to normally endorse the 
inspection reports of the suspended authority. A party shall continue 
to normally endorse the inspection reports of that authority prior to 
suspension, unless the authority of the receiving party decides 
otherwise based on health or safety considerations. The suspension will 
remain in effect until unanimous consent has been reached by the 
parties on the future status of that authority.


Sec. 26.17   Role and composition of the Joint Sectoral Committee.

     (a) A Joint Sectoral Committee is set up to monitor the activities 
under both the transitional and operational phases of this subpart.

[[Page 60144]]

     (b) The Joint Sectoral Committee will be cochaired by a 
representative of the Food and Drug Administration (FDA) for the United 
States and a representative of the European Community (EC) who each 
will have one vote. Decisions will be taken by unanimous consent.
     (c) The Joint Sectoral Committee's functions will include:
     (1) Making a joint assessment, which must be agreed by both 
parties, of the equivalence of the respective authorities;
     (2) Developing and maintaining the list of equivalent authorities, 
including any limitation in terms of inspecting type or products, and 
communicating the list to all authorities and the Joint Committee;
     (3) Providing a forum to discuss issues relating to this subpart, 
including concerns that an authority may be no longer equivalent and 
opportunity to review product coverage; and
     (4) Consideration of the issue of suspension.
     (d) The Joint Sectoral Committee shall meet at the request of 
either party and, unless the cochairs otherwise agree, at least once 
each year. The Joint Committee will be kept informed of the agenda and 
conclusions of meetings of the Joint Sectoral Committee.


Sec. 26.18   Regulatory collaboration.

     (a) The parties and authorities shall inform and consult one 
another, as permitted by law, on proposals to introduce new controls or 
to change existing technical regulations or inspection procedures and 
to provide the opportunity to comment on such proposals.
     (b) The parties shall notify each other in writing of any changes 
to Appendix B of this subpart.


Sec. 26.19   Information relating to quality aspects.

     The authorities will establish an appropriate means of exchanging 
information on any confirmed problem reports, corrective actions, 
recalls, rejected import consignments, and other regulatory and 
enforcement problems for products subject to this subpart.


Sec. 26.20   Alert system.

     (a) The details of an alert system will be developed during the 
transitional period. The system will be maintained in place at all 
times. Elements to be considered in developing such a system are 
described in Appendix E of this subpart.
     (b) Contact points will be agreed between both parties to permit 
authorities to be made aware with the appropriate speed in case of 
quality defect, recalls, counterfeiting, and other problems concerning 
quality, which could necessitate additional controls or suspension of 
the distribution of the product.


Sec. 26.21   Safeguard clause.

     Each party recognizes that the importing country has a right to 
fulfill its legal responsibilities by taking actions necessary to 
ensure the protection of human and animal health at the level of 
protection it deems appropriate. This includes the suspension of the 
distribution, product detention at the border of the importing country, 
withdrawal of the batches and any request for additional information or 
inspection as provided in Sec. 26.12.

Appendix A of Subpart A--List of Applicable Laws, Regulations, and 
Administrative Provisions.

1. For the European Community (EC):

     [Copies of EC documents may be obtained from the European 
Document Research, 1100 17th St. NW., suite 301, Washington, DC 
20036. EC documents may be viewed on the European Commission 
Pharmaceuticals Units web site at ``http://dg3.eudra.org''.]
Council Directive 65/65/EEC of 26 January 1965 on the approximation 
of provisions laid down by law, regulation, or administrative action 
relating to proprietary medicinal products as extended, widened, and 
amended.
Council Directive 75/319/EEC of 20 May 1975 on the approximation of 
provisions laid down by law, regulation or administrative action 
relating to proprietary medicinal products as extended, widened and 
amended.
Council Directive 81/851/EEC of 28 September 1981 on the 
approximation of the laws of the Member States relating to 
veterinary medicinal products, as widened and amended.
Commission Directive 91/356/EEC of 13 June 1991 laying down the 
principles and guidelines of good manufacturing practice for 
medicinal products for human use.
Commission Directive 91/412/EEC of 23 July 1991 laying down the 
principles and guidelines of good manufacturing practice for 
veterinary medicinal products.
Council Regulation EEC No 2309/93 of 22 July 1993 laying down 
Community procedures for the authorization and supervision of 
medicinal products for human and veterinary use and establishing a 
European Agency for the Evaluation of Medicinal Products.
Council Directive 92/25/EEC of 31 March 1992 on the wholesale 
distribution of medicinal products for human use.
Guide to Good Distribution Practice (94/C 63/03).
Current version of the Guide to Good Manufacturing Practice, Rules 
Governing Medicinal Products in the European Community, Volume IV.

2. For the United States:

     [Copies of FDA documents may be obtained from the Government 
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA 
documents, except the FDA Compliance Program Guidance Manual, may be 
viewed on FDA's Internet web site at ``http://www.FDA.gov''.]
Relevant sections of the United States Federal Food, Drug, and 
Cosmetic Act and the United States Public Health Service Act.
Relevant sections of Title 21, United States Code of Federal 
Regulations (CFR) Parts 1-99, Parts 200-299, Parts 500-599, and 
Parts 600-799.
Relevant sections of the FDA Investigations Operations Manual, the 
FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance 
Manual, the FDA Compliance Program Guidance Manual, and other FDA 
guidances.

Appendix B of Subpart A--List of Authorities.

1. For the United States: In the United States, the regulatory 
authority is the Food and Drug Administration.

2. For the European Community: In the European Community, the 
regulatory authorities are the following:

Belgium: Inspection generale de la Pharmacie, Algemene 
Farmaceutische Inspectie.
Denmark: Laegemiddelstyrelsen.
Germany: Bundesministerium fur Gesundheit for immunologicals: Paul-
Ehrlich-Institut, Federal Agency for Sera and Vaccines.
Greece: 
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, Ministry of Health and Welfare, National Drug Organization 
(E.O.F).
Spain: For medicinal products for human use: Ministerio de Sanidad y 
Consumo, Subdireccion General de Control Farmaceutico. For medicinal 
products for veterinary use: Ministerio de Agricultura, Pesca y 
Alimentacion (MAPA), Direccion General de la Produccion Agraria.
France: For medicinal products for human use: Agence du Medicament. 
For veterinary medicinal products: Agence Nationale du Medicament 
Veterinaire.
Ireland: Irish Medicines Board.
Italy: For medicinal products for human use: Ministero della Sanita, 
Dipartimento Farmaci e Farmacovigilanza. For medicinal products for 
veterinary use: Ministero della Sanita, Dipartimento alimenti e 
nutrizione e sanita pubblica veterinaria-Div. IX.
Luxembourg: Division de la Pharmacie et des Medicaments.
Netherlands: Staat der Nederlanden.
Austria: Bundesministerium fur Arbeit, Gesundheit und Soziales.
Portugal: Instituto da Farmacia e do Medicamento (INFARMED).
Finland: Laakelaitos/Lakemedelsverket (National Agency for 
Medicines).
Sweden: Lakemedelsverket-Medical Products Agency.
United Kingdom: For human use and veterinary (non-immunologicals): 
Medicines Control Agency. For veterinary immunologicals: Veterinary 
Medicines Directorate.
European Community: Commission of the European Communities. European 
Agency

[[Page 60145]]

for the Evaluation of Medicinal Products (EMEA).

Appendix C of Subpart A--Indicative List of Products Covered by 
Subpart A.

Recognizing that precise definition of medicinal products and drugs 
are to be found in the legislation referred to above, an indicative 
list of products covered by this arrangement is given below:
    - human medicinal products including prescription and 
nonprescription drugs;
    - human biologicals including vaccines, and immunologicals;
    - veterinary pharmaceuticals, including prescription and 
nonprescription drugs, with the exclusion of veterinary 
immunologicals (Under 9 CFR 101.2 ``veterinary immunologicals'' are 
referred to as ``veterinary biologicals'');
    - premixes for the preparation of veterinary medicated feeds 
(EC), Type A medicated articles for the preparation of veterinary 
medicated feeds (United States);
    - intermediate products and active pharmaceutical ingredients or 
bulk pharmaceuticals (United States)/starting materials (EC).

Appendix D of Subpart A--Criteria for Assessing Equivalence for 
Post- and Preapproval.

I. Legal/Regulatory authority and structures and procedures providing 
for post- and preapproval:

A. Appropriate statutory mandate and jurisdiction.
B. Ability to issue and update binding requirements on GMP's and 
guidance documents.
C. Authority to make inspections, review and copy documents, and to 
take samples and collect other evidence.
D. Ability to enforce requirements and to remove products found in 
violation of such requirements from the market.
E. Substantive current good manufacturing requirements.
F. Accountability of the regulatory authority.
G. Inventory of current products and manufacturers.
H. System for maintaining or accessing inspection reports, samples 
and other analytical data, and other firm/product information 
relating to matters covered by subpart A of this part.

II. Mechanisms in place to assure appropriate professional standards 
and avoidance of conflicts of interest.

III. Administration of the regulatory authority:

A. Standards of education/qualification and training.
B. Effective quality assurance systems measures to ensure adequate 
job performance.
C. Appropriate staffing and resources to enforce laws and 
regulations.

IV. Conduct of inspections:

A. Adequate preinspection preparation, including appropriate 
expertise of investigator/team, review of firm/product and 
databases, and availability of appropriate inspection equipment.
B. Adequate conduct of inspection, including statutory access to 
facilities, effective response to refusals, depth and competence of 
evaluation of operations, systems and documentation; collection of 
evidence; appropriate duration of inspection and completeness of 
written report of observations to firm management.
C. Adequate postinspection activities, including completeness of 
inspectors' report, inspection report review where appropriate, and 
conduct of followup inspections and other activities where 
appropriate, assurance of preservation and retrieval of records.

V. Execution of regulatory enforcement actions to achieve corrections, 
designed to prevent future violations, and to remove products found in 
violation of requirements from the market.

VI. Effective use of surveillance systems:

A. Sampling and analysis.
B. Recall monitoring.
C. Product defect reporting system.
D. Routine surveillance inspections.
E. Verification of approved manufacturing process changes to 
marketing authorizations/approved applications.

VII. Additional specific criteria for preapproval inspections:

A. Satisfactory demonstration through a jointly developed and 
administered training program and joint inspections to assess the 
regulatory authorities' capabilities.
B. Preinspection preparation includes the review of appropriate 
records, including site plans and drug master file or similar 
documentation to enable adequate inspections.
C. Ability to verify chemistry, manufacturing, and control data 
supporting an application is authentic and complete.
D. Ability to assess and evaluate research and development data as 
scientifically sound, especially transfer technology of pilot, scale 
up and full scale production batches.
E. Ability to verify conformity of the onsite processes and 
procedures with those described in the application.
F. Review and evaluate equipment installation, operational and 
performance qualification data, and evaluate test method validation.

Appendix E of Subpart A--Elements to be Considered in Developing a 
Two-Way Alert System.

1. Documentation

- Definition of a crisis/emergency and under what circumstances an 
alert is required
- Standard Operating Procedures (SOP's)
- Mechanism of health hazards evaluation and classification
- Language of communication and transmission of information

2. Crisis Management System

- Crisis analysis and communication mechanisms
- Establishment of contact points
- Reporting mechanisms

3. Enforcement Procedures

- Followup mechanisms
- Corrective action procedures

4. Quality Assurance System

- Pharmacovigilance programme
- Surveillance/monitoring of implementation of corrective action

5. Contact Points

For the purpose of subpart A of this part, the contact points for 
the alert system will be:

A. For the European Community:

the Executive Director of the European Agency for the Evaluation of 
Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London 
E14 4HB, England. Telephone 44-171-418 8400, Fax 418-8416.

B. For the United States :

Biologics: Director, Office of Compliance and Biologics Quality 
(HFM-600), 1401 Rockville Pike, Rockville, MD 20852, phone: 301-827-
6190, fax: 301-594-1944.
Human Drugs: Director, Office of Compliance (HFD-300), MPN I, 7520 
Standish Pl., Rockville, MD 20855-2737, phone: 301-594-0054, fax: 
301-594-2114.
Veterinary Drugs: Director, Office of Surveillance and Compliance 
(HFV-200), MPN II, 7500 Standish Pl., Rockville, MD 20855-2773, 
phone: 301-827-6644, fax: 301-594-1807.

Subpart B--Specific Sector Provisions for Medical Devices


Sec. 26.31   Purpose.

     (a) The purpose of this subpart is to specify the conditions under 
which a party will accept the results of quality system-related 
evaluations and inspections and premarket evaluations of the other 
party with regard to medical devices as conducted by listed conformity 
assessment bodies (CAB's) and to provide for other related cooperative 
activities.
     (b) This subpart is intended to evolve as programs and policies of 
the parties evolve. The parties will review this subpart periodically, 
in order to assess progress and identify potential enhancements to this 
subpart as Food and Drug Administration (FDA) and European Community 
(EC) policies evolve over time.


Sec. 26.32   Scope.

     (a) The provisions of this subpart shall apply to the exchange 
and, where appropriate, endorsement of the following types of reports 
from conformity assessment bodies (CAB's) assessed to be equivalent:
     (1) Under the U.S. system, surveillance/postmarket and initial/
preapproval inspection reports;
     (2) Under the U.S. system, premarket (510(k)) product evaluation 
reports;
     (3) Under the European Community (EC) system, quality system 
evaluation reports; and
     (4) Under the EC system, EC type examination and verification 
reports.

[[Page 60146]]

     (b) Appendix A of this subpart names the legislation, regulations, 
and related procedures under which:
     (1) Products are regulated as medical devices by each party;
     (2) CAB's are designated and confirmed; and
     (3) These reports are prepared.
     (c) For purposes of this subpart, equivalence means that: CAB's in 
the EC are capable of conducting product and quality systems 
evaluations against U.S. regulatory requirements in a manner equivalent 
to those conducted by FDA; and CAB's in the United States are capable 
of conducting product and quality systems evaluations against EC 
regulatory requirements in a manner equivalent to those conducted by EC 
CAB's.


Sec. 26.33   Product coverage.

     (a) There are three components to this subpart each covering a 
discrete range of products:
     (1) Quality System Evaluations. U.S.-type surveillance/postmarket 
and initial/preapproval inspection reports and European Community (EC)-
type quality system evaluation reports will be exchanged with regard to 
all products regulated under both U.S. and EC law as medical devices.
     (2) Product Evaluation. U.S.-type premarket (510(k)) product 
evaluation reports and EC-type-testing reports will be exchanged only 
with regard to those products classified under the U.S. system as Class 
I/Class II-Tier 2 medical devices which are listed in Appendix B of 
this subpart.
     (3) Postmarket Vigilance Reports. Postmarket vigilance reports 
will be exchanged with regard to all products regulated under both U.S. 
and EC law as medical devices.
     (b) Additional products and procedures may be made subject to this 
subpart by agreement of the parties.


Sec. 26.34   Regulatory authorities.

     The regulatory authorities shall have the responsibility of 
implementing the provisions of this subpart, including the designation 
and monitoring of conformity assessment bodies (CAB's). Regulatory 
authorities will be specified in Appendix C of this subpart. Each party 
will promptly notify the other party in writing of any change in the 
regulatory authority for a country.


Sec. 26.35   Length and purpose of transition period.

     There will be a 3-year transition period immediately following the 
date described in Sec. 26.80(a). During the transition period, the 
parties will engage in confidence-building activities for the purpose 
of obtaining sufficient evidence to make determinations concerning the 
equivalence of conformity assessment bodies (CAB's) of the other party 
with respect to the ability to perform quality system and product 
evaluations or other reviews resulting in reports to be exchanged under 
this subpart.


Sec. 26.36   Listing of CAB's.

     Each party shall designate conformity assessment bodies (CAB's) to 
participate in confidence building activities by transmitting to the 
other party a list of CAB's which meet the criteria for technical 
competence and independence, as identified in Appendix A of this 
subpart. The list shall be accompanied by supporting evidence. 
Designated CAB's will be listed in Appendix D of this subpart for 
participation in the confidence building activities once confirmed by 
the importing party. Nonconfirmation would have to be justified based 
on documented evidence.


Sec. 26.37   Confidence building activities.

     (a) At the beginning of the transitional period, the Joint 
Sectoral Group will establish a joint confidence building program 
calculated to provide sufficient evidence of the capabilities of the 
designated conformity assessment bodies (CAB's) to perform quality 
system or product evaluations to the specifications of the parties.
     (b) The joint confidence building program should include the 
following actions and activities:
     (1) Seminars designed to inform the parties and CAB's about each 
party's regulatory system, procedures, and requirements;
     (2) Workshops designed to provide the parties with information 
regarding requirements and procedures for the designation and 
surveillance of CAB's;
     (3) Exchange of information about reports prepared during the 
transition period;
     (4) Joint training exercises; and
     (5) Observed inspections.
     (c) During the transition period, any significant problem that is 
identified with a CAB may be the subject of cooperative activities, as 
resources allow and as agreed to by the regulatory authorities, aimed 
at resolving the problem.
     (d) Both parties will exercise good faith efforts to complete the 
confidence building activities as expeditiously as possible to the 
extent that the resources of the parties allow.
     (e) Both the parties will each prepare annual progress reports 
which will describe the confidence building activities undertaken 
during each year of the transition period. The form and content of the 
reports will be determined by the parties through the Joint Sectoral 
Committee.


Sec. 26.38   Other transition period activities.

     (a) During the transition period, the parties will jointly 
determine the necessary information which must be present in quality 
system and product evaluation reports.
     (b) The parties will jointly develop a notification and alert 
system to be used in case of defects, recalls, and other problems 
concerning product quality that could necessitate additional actions 
(e.g., inspections by the parties of the importing country) or 
suspension of the distribution of the product.


Sec. 26.39   Equivalence assessment.

     (a) In the final 6 months of the transition period, the parties 
shall proceed to a joint assessment of the equivalence of the 
conformity assessment bodies (CAB's) that participated in the 
confidence building activities. CAB's will be determined to be 
equivalent provided they have demonstrated proficiency through the 
submission of a sufficient number of adequate reports. CAB's may be 
determined to be equivalent with regard to the ability to perform any 
type of quality system or product evaluation covered by this subpart 
and with regard to any type of product covered by this subpart. The 
parties shall develop a list contained in Appendix E of this subpart of 
CAB's determined to be equivalent, which shall contain a full 
explanation of the scope of the equivalency determination, including 
any appropriate limitations, with regard to performing any type of 
quality system or product evaluation.
     (b) The parties shall allow CAB's not listed for participation in 
this subpart, or listed for participation only as to certain types of 
evaluations, to apply for participation in this subpart once the 
necessary measures have been taken or sufficient experience has been 
gained, in accordance with Sec. 26.46.
     (c) Decisions concerning the equivalence of CAB's must be agreed 
to by both parties.


Sec. 26.40   Start of the operational period.

     (a) The operational period will start at the end of the transition 
period after the parties have developed the list of conformity 
assessment bodies (CAB's) found to be equivalent. The provisions of 
Secs. 26.40, 26.41, 26.42, 26.43, 26.44, 26.45, and 26.46 will apply 
only with regard to listed CAB's and only to the extent of any 
specifications and

[[Page 60147]]

limitations contained on the list with regard to a CAB.
     (b) The operational period will apply to quality system evaluation 
reports and product evaluation reports generated by CAB's listed in 
accordance with this subpart for the evaluations performed in the 
respective territories of the parties, except if the parties agree 
otherwise.


Sec. 26.41   Exchange and endorsement of quality system evaluation 
reports.

     (a) Listed European Community (EC) conformity assessment bodies 
(CAB's) will provide FDA with reports of quality system evaluations, as 
follows:
     (1) For preapproval quality system evaluations, EC CAB's will 
provide full reports; and
     (2) For surveillance quality system evaluations, EC CAB's will 
provide abbreviated reports.
     (b) Listed U.S. CAB's will provide to the EC Notified Body of the 
manufacturer's choice:
     (1) Full reports of initial quality system evaluations;
     (2) Abbreviated reports of quality systems surveillance audits.
     (c) If the abbreviated reports do not provide sufficient 
information, the importing party may request additional clarification 
from the CAB.
     (d) Based on the determination of equivalence in light of the 
experience gained, the quality system evaluation reports prepared by 
the CAB's listed as equivalent will normally be endorsed by the 
importing party, except under specific and delineated circumstances. 
Examples of such circumstances include indications of material 
inconsistencies or inadequacies in a report, quality defects identified 
in postmarket surveillance or other specific evidence of serious 
concern in relation to product quality or consumer safety. In such 
cases, the importing party may request clarification from the exporting 
party which may lead to a request for reinspection. The parties will 
endeavor to respond to requests for clarification in a timely manner. 
Where divergence is not clarified in this process, the importing party 
may carry out the quality system evaluation.


Sec. 26.42   Exchange and endorsement of product evaluation reports.

     (a) European Community (EC) conformity assessment bodies (CAB's) 
listed for this purpose will, subject to the specifications and 
limitations on the list, provide to FDA 510(k) premarket notification 
assessment reports prepared to U.S. medical device requirements.
     (b) U.S. CAB's will, subject to the specifications and limitations 
on the list, provide to the EC Notified Body of the manufacturer's 
choice, type examination, and verification reports prepared to EC 
medical device requirements.
     (c) Based on the determination of equivalence in light of the 
experience gained, the product evaluation reports prepared by the CAB's 
listed as equivalent will normally be endorsed by the importing party, 
except under specific and delineated circumstances. Examples of such 
circumstances include indications of material inconsistencies, 
inadequacies, or incompleteness in a product evaluation report, or 
other specific evidence of serious concern in relation to product 
safety, performance, or quality. In such cases, the importing party may 
request clarification from the exporting party which may lead to a 
request for a reevaluation. The parties will endeavor to respond to 
requests for clarification in a timely manner. Endorsement remains the 
responsibility of the importing party.


Sec. 26.43   Transmission of quality system evaluation reports.

     Quality system evaluation reports covered by Sec. 26.41 concerning 
products covered by this subpart shall be transmitted to the importing 
party within 60-calendar days of a request by the importing party. 
Should a new inspection be requested, the time period shall be extended 
by an additional 30-calendar days. A party may request a new 
inspection, for cause, identified to the other party. If the exporting 
party cannot perform an inspection within a specified period of time, 
the importing party may perform an inspection on its own.


Sec. 26.44   Transmission of product evaluation reports.

     Transmission of product evaluation reports will take place 
according to the importing party's specified procedures.


Sec. 26.45   Monitoring continued equivalence.

     Monitoring activities will be carried out in accordance with 
Sec. 26.69.


Sec. 26.46   Listing of additional CAB's.

     (a) During the operational period, additional conformity 
assessment bodies (CAB's) will be considered for equivalence using the 
procedures and criteria described in Secs. 26.36, 26.37, and 26.39, 
taking into account the level of confidence gained in the overall 
regulatory system of the other party.
     (b) Once a designating authority considers that such CAB's, having 
undergone the procedures of Secs. 26.36, 26.37, and 26.39, may be 
determined to be equivalent, it will then designate those bodies on an 
annual basis. Such procedures satisfy the procedures of Sec. 26.66(a) 
and (b).
     (c) Following such annual designations, the procedures for 
confirmation of CAB's under Sec. 26.66(c) and (d) shall apply.


Sec. 26.47   Role and composition of the Joint Sectoral Committee.

     (a) The Joint Sectoral Committee for this subpart is set up to 
monitor the activities under both the transitional and operational 
phases of this subpart.
     (b) The Joint Sectoral Committee will be cochaired by a 
representative of the Food and Drug Administration (FDA) for the United 
States and a representative of the European Community (EC) who will 
each have one vote. Decisions will be taken by unanimous consent.
     (c) The Joint Sectoral Committee's functions will include:
     (1) Making a joint assessment of the equivalence of conformity 
assessment bodies (CAB's);
     (2) Developing and maintaining the list of equivalent CAB's, 
including any limitation in terms of their scope of activities and 
communicating the list to all authorities and the Joint Committee 
described in subpart C of this part;
     (3) Providing a forum to discuss issues relating to this subpart, 
including concerns that a CAB may no longer be equivalent and 
opportunity to review product coverage; and
     (4) Consideration of the issue of suspension.


Sec. 26.48   Harmonization.

     During both the transitional and operational phases of this 
subpart, both parties intend to continue to participate in the 
activities of the Global Harmonization Task Force (GHTF) and utilize 
the results of those activities to the extent possible. Such 
participation involves developing and reviewing documents developed by 
the GHTF and jointly determining whether they are applicable to the 
implementation of this subpart.


Sec. 26.49   Regulatory cooperation.

     (a) The parties and authorities shall inform and consult with one 
another, as permitted by law, of proposals to introduce new controls or 
to change existing technical regulations or inspection procedures and 
to provide the opportunity to comment on such proposals.
     (b) The parties shall notify each other in writing of any changes 
to Appendix A of this subpart.

[[Page 60148]]

Sec. 26.50   Alert system and exchange of postmarket vigilance reports.

     (a) An alert system will be set up during the transition period 
and maintained thereafter by which the parties will notify each other 
when there is an immediate danger to public health. Elements of such a 
system will be described in an Appendix F of this subpart. As part of 
that system, each party shall notify the other party of any confirmed 
problem reports, corrective actions, or recalls. These reports are 
regarded as part of ongoing investigations.
     (b) Contact points will be agreed between both parties to permit 
authorities to be made aware with the appropriate speed in case of 
quality defect, batch recalls, counterfeiting and other problems 
concerning quality, which could necessitate additional controls or 
suspension of the distribution of the product.

Appendix A of Subpart B--Relevant Legislation, Regulations, and 
Procedures.

1. For the European Community (EC) the following legislation applies to 
Sec. 26.42(a) of this subpart:

     [Copies of EC documents may be obtained from the European 
Document Research, 1100 17th St. NW., suite 301, Washington, DC 
20036.]
a. Council Directive 90/385/EEC of 20 June 1990 on active 
implantable medical devices
    OJ No. L 189, 20.7. 1990, p. 17. Conformity assessment 
procedures.
    Annex 2 (with the exception of section 4)
    Annex 4
    Annex 5
b. Council Directive 93/42/EEC of 14 June 1993 on Medical Devices OJ 
No. L 169,12.7.1993, p.1. Conformity assessment procedures.
    Annex 2 (with the exception of section 4)
    Annex 3
    Annex 4
    Annex 5
    Annex 6

2. For the United States, the following legislation applies to 
Sec. 26.32(a):

     [Copies of FDA documents may be obtained from the Government 
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents 
may be viewed on FDA's Internet web site at ``http://www.fda.gov''.]
a. The Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 et seq.
b. The Public Health Service Act, 42 U.S.C. 201 et seq.
c. Regulations of the United States Food and Drug Administration 
found at 21 CFR, in particular, Parts 800 to 1299.
d. Medical Devices; Third Party Review of Selected Premarket 
Notifications; Pilot Program, 61 FR 14789-14796 (April 3, 1996).
e. Draft Guidance Document on Accredited Persons Program, 63 FR 
28392 (May 22, 1998).
f. Draft Guidance for Staff, Industry and Third Parties, Third Party 
Programs under the Sectoral Annex on Medical Devices to the 
Agreement on Mutual Recognition Between the United States of America 
and the European Community (MRA), 63 FR 36240 (July 2, 1998).
g. Guidance Document on Use of Standards, 63 FR 9561 (February 25, 
1998).

Appendix B of Subpart B--Scope of Product Coverage.

1. Initial Coverage of the Transition Period

Upon entry into force of this subpart as described in Sec. 26.80 (it 
is understood that the date of entry into force will not occur prior 
to June 1, 1998, unless the parties decide otherwise), products 
qualifying for the transitional arrangements under this subpart 
include:
    a. All Class I products requiring premarket evaluations in the 
United States--see Table 1.
    b. Those Class II products listed in Table 2.

2. During the Transition Period

The parties will jointly identify additional product groups, 
including their related accessories, in line with their respective 
priorities as follows:
    a. Those for which review may be based primarily on written 
guidance which the parties will use their best efforts to prepare 
expeditiously; and
    b. Those for which review may be based primarily on 
international standards, in order for the parties to gain the 
requisite experience.
The corresponding additional product lists will be phased in on an 
annual basis. The parties may consult with industry and other 
interested parties in determining which products will be added.

3. Commencement of the Operational Period

    a. At the commencement of the operational period, product 
coverage shall extend to all Class I/II products covered during the 
transition period.
    b. FDA will expand the program to categories of Class II devices 
as is consistent with the results of the pilot, and with FDA's 
ability to write guidance documents if the device pilot for the 
third party review of medical devices is successful. The MRA will 
cover to the maximum extent feasible all Class II devices listed in 
Table 3 for which FDA-accredited third party review is available in 
the United States.

4. Unless explicitly included by joint decision of the parties, this 
part does not cover any U.S. Class II-tier 3 or any Class III product 
under either system.

     [The lists of medical devices included in these tables are 
subject to change as a result of the Food and Drug Administration 
Modernization Act of 1997.]

Table 1.--Class I Products Requiring Premarket Evaluations in the United
States, Included in Scope of Product Coverage at Beginning of Transition
                                Period\1\
------------------------------------------------------------------------
          21 CFR Section No.                    Regulation Name
------------------------------------------------------------------------
                                           Product Code--Device Name
------------------------------------------------------------------------
Anesthesiology Panel (21 CFR Part
 868)
    868.1910                           Esophageal Stethoscope
                                       BZW--Stethoscope, Esophageal
    868.5620                           Breathing Mouthpiece
                                       BYP--Mouthpiece, Breathing
    868.5640                           Medicinal Nonventilatory
                                        Nebulizer (Atomizer)
                                       CCQ--Nebulizer, Medicinal,
                                        Nonventilatory (Atomizer)
    868.5675                           Rebreathing Device
                                       BYW--Device, Rebreathing
    868.5700                           Nonpowered Oxygen Tent
                                       FOG--Hood, Oxygen, Infant
                                       BYL--Tent, Oxygen
    868.6810                           Tracheobronchial Suction Catheter
                                       BSY--Catheters, Suction,
                                        Tracheobronchial
Cardiovascular Panel
    (None)
Dental Panel (21 CFR Part 872)
    872.3400                           Karaya and Sodium Borate With or
                                        Without Acacia Denture Adhesive
                                       KOM--Adhesive, Denture, Acacia
                                        and Karaya With Sodium Borate

[[Page 60149]]

    872.3700                           Dental Mercury (U.S.P.)
                                       ELY--Mercury
    872.4200                           Dental Handpiece and Accessories
                                       EBW--Controller, Food, Handpiece
                                        and Cord
                                       EFB--Handpiece, Air-Powered,
                                        Dental
                                       EFA--Handpiece, Belt and/or Gear
                                        Driven, Dental
                                       EGS--Handpiece, Contra- and Right-
                                        Angle Attachment, Dental
                                       EKX--Handpiece, Direct Drive, AC-
                                        Powered
                                       EKY--Handpiece, Water-Powered
    872.6640                           Dental Operative Unit and
                                        Accessories
                                       EIA--Unit, Operative Dental
Ear, Nose, and Throat Panel (21 CFR
 Part 874)
    874.1070                           Short Increment Sensitivity Index
                                        (SISI) Adapter
                                       ETR--Adapter, Short Increment
                                        Sensitivity Index (SISI)
    874.1500                           Gustometer
                                       ETM--Gustometer
    874.1800                           Air or Water Caloric Stimulator
                                       KHH--Stimulator, Caloric-Air
                                       ETP--Stimulator, Caloric-Water
    874.1925                           Toynbee Diagnostic Tube
                                       ETK--Tube, Toynbee Diagnostic
    874.3300                           Hearing Aid
                                       LRB--Face Plate Hearing-Aid
                                       ESD--Hearing-aid, Air-Conduction
    874.4100                           Epistaxis Balloon
                                       EMX--Balloon, Epistaxis
    874.5300                           ENT Examination and Treatment
                                        Unit
                                       ETF--Unit, Examining/Treatment,
                                        ENT
    874.5550                           Powered Nasal Irrigator
                                       KMA--Irrigator, Powered Nasal
    874.5840                           Antistammering Device
                                       KTH--Device, Anti-Stammering
Gastroenterology--Urology Panel (21
 CFR Part 876)
    876.5160                           Urological Clamp for Males
                                       FHA--Clamp, Penile
    876.5210                           Enema Kit
                                       FCE--Kit, Enema, (for Cleaning
                                        Purpose)
    876.5250                           Urine Collector and Accessories
                                       FAQ--Bag, Urine Collection, Leg,
                                        for External Use
General Hospital Panel (21 CFR Part
 880)
    880.5270                           Neonatal Eye Pad
                                       FOK--Pad, Neonatal Eye
    880.5420                           Pressure Infusor for an I.V. Bag
                                       KZD--Infusor, Pressure, for I.V.
                                        Bags
    880.5680                           Pediatric Position Holder
                                       FRP--Holder, Infant Position
    880.6250                           Patient Examination Glove
                                       LZB--Finger Cot
                                       FMC--Glove, Patient Examination
                                       LYY--Glove, Patient Examination,
                                        Latex
                                       LZA--Glove, Patient Examination,
                                        Poly
                                       LZC--Glove, Patient Examination,
                                        Speciality
                                       LYZ--Glove, Patient Examination,
                                        Vinyl
    880.6375                           Patient Lubricant
                                       KMJ--Lubricant, Patient
    880.6760                           Protective Restraint
                                       BRT--Restraint, Patient,
                                        Conductive
                                       FMQ--Restraint, Protective
Neurology Panel (21 CFR Part 882)
    882.1030                           Ataxiagraph
                                       GWW--Ataxiagraph
    882.1420                           Electroencephalogram (EEG) Signal
                                        Spectrum Analyzer
                                       GWS--Analyzer, Spectrum,
                                        Electroencephalogram Signal
    882.4060                           Ventricular Cannula
                                       HCD--Cannula, Ventricular
    882.4545                           Shunt System Implantation
                                        Instrument
                                       GYK--Instrument, Shunt System
                                        Implantation
    882.4650                           Neurosurgical Suture Needle
                                       HAS--Needle, Neurosurgical Suture

[[Page 60150]]

    882.4750                           Skull Punch
                                       GXJ--Punch, Skull
Obstetrics and Gynecology Panel
    (None)
Ophthalmology Panel (21 CFR Part 886)
    886.1780                           Retinoscope
                                       HKM--Retinoscope, Battery-Powered
    886.1940                           Tonometer Sterilizer
                                       HKZ--Sterilizer, Tonometer
    886.4070                           Powered Corneal Burr
                                       HQS--Burr, Corneal, AC-Powered
                                       HOG--Burr, Corneal, Battery-
                                        Powered
                                       HRG--Engine, Trephine,
                                        Accessories, AC-Powered
                                       HFR--Engine, Trephine,
                                        Accessories, Battery-Powered
                                       HLD--Engine, Trephine,
                                        Accessories, Gas-Powered
    886.4370                           Keratome
                                       HNO--Keratome, AC-Powered
                                       HMY--Keratome, Battery-Powered
    886.5850                           Sunglasses (Nonprescription)
                                       HQY--Sunglasses (Nonprescription
                                        Including Photosensitive)
Orthopedic Panel (21 CFR Part 888)
    888.1500                           Goniometer
                                       KQX--Goniometer, AC-Powered
    888.4150                           Calipers for Clinical Use
                                       KTZ--Caliper
Physical Medicine Panel (21 CFR Part
 890)
    890.3850                           Mechanical Wheelchair
                                       LBE--Stroller, Adaptive
                                       IOR--Wheelchair, Mechanical
    890.5180                           Manual Patient Rotation Bed
                                       INY--Bed, Patient Rotation,
                                        Manual
    890.5710                           Hot or Cold Disposable Pack
                                       IMD--Pack, Hot or Cold,
                                        Disposable
Radiology Panel (21 CFR Part 892)
    892.1100                           Scintillation (Gamma) Camera
                                       IYX--Camera, Scintillation
                                        (Gamma)
    892.1110                           Positron Camera
                                       IZC--Camera, Positron
    892.1300                           Nuclear Rectilinear Scanner
                                       IYW--Scanner, Rectilinear,
                                        Nuclear
    892.1320                           Nuclear Uptake Probe
                                       IZD--Probe, Uptake, Nuclear
    892.1330                           Nuclear Whole Body Scanner
                                       JAM--Scanner, Whole Body, Nuclear
    892.1410                           Nuclear Electrocardiograph
                                        Synchronizer
                                       IVY--Synchronizer,
                                        Electrocardiograph, Nuclear
    892.1890                           Radiographic Film Illuminator
                                       IXC--Illuminator, Radiographic-
                                        Film
                                        JAG--Illuminator, Radiographic-
                                        Film, Explosion-Proof
    892.1910                           Radiographic Grid
                                       IXJ--Grid, Radiographic
    892.1960                           Radiographic Intensifying Screen
                                       EAM--Screen, Intensifying,
                                        Radiographic
    892.1970                           Radiographic ECG/Respirator
                                        Synchronizer
                                       IXO--Synchronizer, ECG/
                                        Respirator, Radiographic
    892.5650                           Manual Radionuclide Applicator
                                        System
                                       IWG--System, Applicator,
                                        Radionuclide, Manual
General and Plastic Surgery Panel (21
 CFR Part 878)
     878.4200                          Introduction/Drainage Catheter
                                        and Accessories
                                       KGZ--Accessories, Catheter
                                       GCE--Adaptor, Catheter
                                       FGY--Cannula, Injection
                                       GBA--Catheter, Balloon Type
                                       GBZ--Catheter, Cholangiography
                                       GBQ--Catheter, Continuous
                                        Irrigation
                                       GBY--Catheter, Eustachian,
                                        General & Plastic Surgery
                                       JCY--Catheter, Infusion
                                       GBX--Catheter, Irrigation
                                       GBP--Catheter, Multiple Lumen

[[Page 60151]]

                                       GBO--Catheter, Nephrostomy,
                                        General & Plastic Surgery
                                       GBN--Catheter, Pediatric, General
                                        & Plastic Surgery
                                       GBW--Catheter, Peritoneal
                                       GBS--Catheter, Ventricular,
                                        General & Plastic Surgery
                                       GCD--Connector, Catheter
                                       GCC--Dilator, Catheter
                                       GCB--Needle, Catheter
    878.4320                           Removable Skin Clip
                                       FZQ--Clip, Removable (Skin)
    878.4460                           Surgeon's Gloves
                                       KGO--Surgeon's Gloves
    878.4680                           Nonpowered, Single Patient,
                                        Portable Suction Apparatus
                                       GCY--Apparatus, Suction, Single
                                        Patient Use, Portable,
                                        Nonpowered
    878.4760                           Removable Skin Staple
                                       GDT--Staple, Removable (Skin)
    878.4820                           AC-Powered, Battery-Powered, and
                                        Pneumatically Powered Surgical
                                        Instrument Motors and
                                        Accessories/Attachments
                                       GFG--Bit, Surgical
                                       GFA--Blade, Saw, General &
                                        Plastic Surgery
                                       DWH--Blade, Saw, Surgical,
                                        Cardiovascular
                                       BRZ--Board, Arm (With Cover)
                                       GFE--Brush, Dermabrasion
                                       GFF--Bur, Surgical, General &
                                        Plastic Surgery
                                       KDG--Chisel (Osteotome)
                                       GFD--Dermatome
                                       GFC--Driver, Surgical, Pin
                                       GFB--Head, Surgical, Hammer
                                       GEY--Motor, Surgical Instrument,
                                        AC-Powered
                                       GET--Motor, Surgical Instrument,
                                        Pneumatic Powered
                                       DWI--Saw, Electrically Powered
                                       KFK--Saw, Pneumatically Powered
                                       HAB--Saw, Powered, and
                                        Accessories
    878.4960                           Air or AC-Powered Operating Table
                                        and Air or AC-Powered Operating
                                        Chair & Accessories
                                       GBB--Chair, Surgical, AC-Powered
                                       FQO--Table, Operating-Room, AC-
                                        Powered
                                       GDC--Table, Operating-Room,
                                        Electrical
                                        FWW--Table, Operating-Room,
                                        Pneumatic
                                       JEA--Table, Surgical with
                                        Orthopedic Accessories, AC-
                                        Powered
    880.5090                           Liquid Bandage
                                       KMF--Bandage, Liquid
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other
  medical device identifiers may be viewed on FDA's Internet Web Site at
  ``http://www.fda.gov/cdrh/prodcode.html''.


Table 2.--Class II Medical Devices Included in Scope of Product Coverage
  at Beginning of Transition Period (United States to develop guidance
 documents identifying U.S. requirements and European Community (EC) to
          identify standards needed to meet EC requirements)\1\
------------------------------------------------------------------------
     Panel        21 CFR Section              Regulation Name
----------------        No.       --------------------------------------
                ------------------
                                         Product Code--Device Name
------------------------------------------------------------------------
    RA           892.1000          Magnetic Resonance Diagnostic Device
                                   MOS--COIL, Magnetic Resonance,
                                    Specialty
                                   LNH--System, Nuclear Magnetic
                                    Resonance Imaging
                                   LNI--System, Nuclear Magnetic
                                    Resonance Spectroscopic
Diagnostic
 Ultrasound:
    RA           892.1540          Nonfetal Ultrasonic Monitor
                                   JAF--Monitor, Ultrasonic, Nonfetal
    RA           892.1550          Ultrasonic Pulsed Doppler Imaging
                                    System
                                   IYN--System, Imaging, Pulsed Doppler,
                                    Ultrasonic
    RA           892.1560          Ultrasonic Pulsed Echo Imaging System
                 ................  IYO--System, Imaging, Pulsed Echo,
                                    Ultrasonic
    RA           892.1570          Diagnostic Ultrasonic Transducer
                 ................  ITX--Transducer, Ultrasonic,
                                    Diagnostic

[[Page 60152]]

Diagnostic X-
 Ray Imaging
 Devices
 (except
 mammographic x-
 ray systems):
    RA           892.1600          Angiographic X-Ray System
                                   IZI--System, X-Ray, Angiographic
    RA           892.1650          Image-Intensified Fluoroscopic X-Ray
                                    System
                                   MQB--Solid State X-Ray Imager (Flat
                                    Panel/Digital Imager)
                                   JAA--System, X-Ray, Fluoroscopic,
                                    Image-Intensified
    RA           892.1680          Stationary X-Ray System
                                   KPR--System, X-Ray, Stationary
    RA           892.1720          Mobile X-Ray System
                                   IZL--System, X-Ray, Mobile
    RA           892.1740          Tomographic X-Ray System
                                   IZF--System, X-Ray, Tomographic
    RA           892.1750          Computed Tomography X-Ray System
                                   JAK--System, X-Ray, Tomography,
                                    Computed
ECG-Related
 Devices:
    CV           870.2340          Electrocardiograph
                 ................  DPS--Electrocardiograph
                 ................  MLC--Monitor, ST Segment
    CV           870.2350          Electrocardiograph Lead Switching
                                    Adaptor
                                   DRW--Adaptor, Lead Switching,
                                    Electrocardiograph
    CV           870.2360          Electrocardiograph Electrode
                                   DRX--Electrode, Electrocardiograph
    CV           870.2370          Electrocardiograph Surface Electrode
                                    Tester
                                   KRC--Tester, Electrode, Surface,
                                    Electrocardiographic
    NE           882.1400          Electroencephalograph
                                   GWQ--Electroencephalograph
    HO           880.5725          Infusion Pump (external only)
                                   MRZ--Accessories, Pump, Infusion
                                   FRN--Pump, Infusion
                                   LZF--Pump, Infusion, Analytical
                                    Sampling
                                   MEB--Pump, Infusion, Elastomeric
                                   LZH--Pump, Infusion, Enteral
                                   MHD--Pump, Infusion, Gallstone
                                    Dissolution
                                   LZG--Pump, Infusion, Insulin
                                   MEA--Pump, Infusion, PCA
Ophthalmic
 Instruments:
    OP            886.1570         Ophthalmoscope
                                   HLI--Ophthalmoscope, AC-Powered
                                   HLJ--Ophthalmoscope, Battery-Powered
    OP           886.1780          Retinoscope
                                   HKL--Retinoscope, AC-Powered
    OP           886.1850          AC-Powered Slit-Lamp Biomicroscope
                                   HJO--Biomicroscope, Slit-Lamp, AC-
                                    Powered
    OP           886.4150          Vitreous Aspiration and Cutting
                                    Instrument
                                   MMC--Dilator, Expansive Iris
                                    (Accessory)
                                   HQE--Instrument, Vitreous Aspiration
                                    and Cutting, AC-Powered
                                   HKP--Instrument, Vitreous Aspiration
                                    and Cutting, Battery-Powered
                                   MLZ--Vitrectomy, Instrument Cutter
    OP           886.4670          Phacofragmentation System
                                   HQC--Unit, Phacofragmentation
    SU           878.4580          Surgical Lamp
                                   HBI--Illuminator, Fiberoptic,
                                    Surgical Field
                                   FTF--Illuminator, Nonremote
                                   FTG--Illuminator, Remote
                                   HJE--Lamp, Fluorescein, AC-Powered
                                   FQP--Lamp, Operating-Room
                                   FTD--Lamp, Surgical
                                   GBC--Lamp, Surgical, Incandescent
                                   FTA--Light, Surgical, Accessories
                                   FSZ--Light, Surgical, Carrier
                                   FSY--Light, Surgical, Ceiling Mounted
                                   FSX--Light, Surgical, Connector
                                   FSW--Light, Surgical, Endoscopic
                                   FST--Light, Surgical, Fiberoptic
                                   FSS--Light, Surgical, Floor Standing

[[Page 60153]]

                                   FSQ--Light, Surgical, Instrument
    NE           882.5890          Transcutaneous Electrical Nerve
                                    Stimulator for Pain Relief
                                   GZJ--Stimulator, Nerve,
                                    Transcutaneous, For Pain Relief
                                   Noninvasive Blood Pressure
                                    Measurement Devices:
    CV           870.1120          Blood Pressure Cuff
                                   DXQ--Cuff, Blood-Pressure
    CV           870.1130          Noninvasive Blood Pressure
                                    Measurement System (except
                                    nonoscillometric)
                                   DXN--System, Measurement, Blood-
                                    Pressure, Noninvasive
    HO           880.6880          Steam Sterilizer (greater than 2
                                    cubic feet)
                                   FLE--Sterilizer, Steam
Clinical
 Thermometers:
    HO           880.2910          Clinical Electronic Thermometer
                                    (except tympanic or pacifier)
                                   FLL--Thermometer, Electronic,
                                    Clinical
    AN           868.5630          Nebulizer
                                   CAF--Nebulizer (Direct Patient
                                    Interface)
    AN           868.5925          Powered Emergency Ventilator
Hypodermic
 Needles and
 Syringes
 (except
 antistick and
 self-
 destruct):
    HO           880.5570          Hypodermic Single Lumen Needle
                                   MMK--Container, Sharpes
                                   FMI--Needle, Hypodermic, Single Lumen
                                   MHC--Port, Intraosseous, Implanted
    HO           880.5860          Piston Syringe
                                   FMF--Syringe, Piston
    OR           888.3020          Intramedullary Fixation Rod
                                   HSB--ROD, Fixation, Intramedullary
                                    and Accessories
External
 Fixators
 (except
 devices with
 no external
 components):
    OR           888.3030          Single/Multiple Component Metallic
                                    Bone Fixation Appliances and
                                    Accessories
                                   KTT--Appliance, Fixation, Nail/Blade/
                                    Plate Combination, Multiple
                                    Component
    OR           888.3040          Smooth or Threaded Metallic Bone
                                    Fixation Fastener
                                   JEC--Component, Traction, Invasive
                                   HTY--Pin, Fixation, Smooth
                                   JDW--Pin, Fixation, Threaded
Selected Dental
 Materials:
    DE           872.3060          Gold-Based Alloys and Precious Metal
                                    Alloys for Clinical Use
                                   EJT--Alloy, Gold Based, For Clinical
                                    Use
                                   EJS--Alloy, Precious Metal, For
                                    Clinical Use
    DE           872.3200          Resin Tooth Bonding Agent
                                   KLE--Agent, Tooth Bonding, Resin
    DE           872.3275          Dental Cement
                                   EMA--Cement, Dental
                                   EMB--Zinc Oxide Eugenol
    DE           872.3660          Impression Material
                                   ELW--Material, Impression
    DE           872.3690          Tooth Shade Resin Material
                                   EBF--Material, Tooth Shade, Resin
    DE            872.3710         Base Metal Alloy
                                   EJH--Metal, Base
Latex Condoms:
    OB           884.5300          Condom
                                   HIS--Condom
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other
  medical device identifiers may be viewed on FDA's Internet Web Site at
  ``http://www.fda.gov/cdrh/prodcode.html''.


  Table 3.--Medical Devices for Possible Inclusion in Scope of Product
                  Coverage During Operational Period\1\
------------------------------------------------------------------------
  Product Family   21 CFR Section No     Device Name          Tier
------------------------------------------------------------------------
Anesthesiology
 Panel
    Anesthesia     868.5160           Gas machine for   2
     Devices                           anesthesia or
                                       analgesia
                   868.5270           Breathing system  2
                                       heater

[[Page 60154]]

                   868.5440           Portable oxygen   2
                                       generator
                   868.5450           Respiratory gas   2
                                       humidifier
                   868.5630           Nebulizer         2
                   868.5710           Electrically       2
                                       powered oxygen
                                       tent
                   868.5880           Anesthetic        2
                                       vaporizer
    Gas Analyser   868.1040           Powered           2
                                       Algesimeter
                   868.1075           Argon gas         2
                                       analyzer
                   868.1400           Carbon dioxide    2
                                       gas analyzer
                   868.1430           Carbon monoxide   2
                                       gas analyzer
                   868.1500           Enflurane gas     2
                                       analyzer
                   868.1620           Halothane gas     2
                                       analyzer
                   868.1640           Helium gas        2
                                       analyzer
                   868.1670           Neon gas          2
                                       analyzer
                   868.1690           Nitrogen gas      2
                                       analyzer
                   868.1700           Nitrous oxide     2
                                       gas analyzer
                   868.1720           Oxygen gas        2
                                       analyzer
                   868.1730           Oxygen uptake     2
                                       computer
    Peripheral     868.2775           Electrical        2
     Nerve                             peripheral
     Stimulators                       nerve
                                       stimulator
    Respiratory    868.1750           Pressure          2
     Monitoring                        plethysmograph
                   868.1760           Volume            2
                                       plethysmograph
                   868.1780           Inspiratory       2
                                       airway pressure
                                       meter
                   868.1800           Rhinoanemometer   2
                   868.1840           Diagnostic        2
                                       spirometer
                   868.1850           Monitoring        2
                                       spirometer
                   868.1860           Peak-flow meter   2
                                       for spirometry
                   868.1880           Pulmonary-        2
                                       function data
                                       calculator
                   868.1890           Predictive        2
                                       pulmonary-
                                       function value
                                       calculator
                   868.1900           Diagnostic        2
                                       pulmonary-
                                       function
                                       interpretation
                                       calculator
                   868.2025           Ultrasonic air    2
                                       embolism
                                       monitor
                   868.2375           Breathing         2
                                       frequency
                                       monitor (except
                                       apnea
                                       detectors)
                   868.2480           Cutaneous carbon  2
                                       dioxide (PcCO<INF>2)
                                       monitor
                   868.2500           Cutaneous oxygen  2
                                       monitor (for an
                                       infant not
                                       under gas
                                       anesthesia)
                   868.2550           Pneumotachomomet  2
                                       er
                   868.2600           Airway pressure   2
                                       monitor
                   868.5665           Powered           2
                                       percussor
                   868.5690           Incentive         2
                                       spirometer
    Ventilator     868.5905           Noncontinuous     2
                                       ventilator
                                       (IPPB)
                   868.5925           Powered           2
                                       emergency
                                       ventilator
                   868.5935           External          2
                                       negative
                                       pressure
                                       ventilator
                   868.5895           Continuous        2
                                       ventilator
                   868.5955           Intermittent      2
                                       mandatory
                                       ventilation
                                       attachment
                   868.6250           Portable air      2
                                       compressor
Cardiovascular
 Panel
    Cardiovascula  870.1425           Programmable      2
     r Diagnostic                      diagnostic
                                       computer
                   870.1450           Densitometer      2
                   870.2310           Apex cardiograph  2
                                       (vibrocardiogra
                                       ph)
                   870.2320           Ballistocardiogr  2
                                       aph
                   870.2340           Electrocardiogra  2
                                       ph
                   870.2350           Electrocardiogra  1
                                       ph lead
                                       switching
                                       adaptor
                   870.2360           Electrocardiogra  2
                                       ph electrode
                   870.2370           Electrocardiogra  2
                                       ph surface
                                       electrode
                                       tester
                   870.2400           Vectorcardiograp  1
                                       h
                   870.2450           Medical cathode-  1
                                       ray tube
                                       display
                   870.2675           Oscillometer      2
                   870.2840           Apex              2
                                       cardiographic
                                       transducer
                   870.2860           Heart sound       2
                                       transducer

[[Page 60155]]

    Cardiovascula                     Valve, pressure
     r Monitoring                      relief,
                                       cardiopulmonary
                                       bypass
                   870.1100           Blood pressure    2
                                       alarm
                   870.1110           Blood pressure    2
                                       computer
                   870.1120           Blood pressure    2
                                       cuff
                   870.1130           Noninvasive       2
                                       blood pressure
                                       measurement
                                       system
                   870.1140           Venous blood      2
                                       pressure
                                       manometer
                   870.1220           Electrode         2
                                       recording
                                       catheter or
                                       electrode
                                       recording probe
                   870.1270           Intracavitary     2
                                       phonocatheter
                                       system
                   870.1875           Stethoscope       2
                                       (electronic)
                   870.2050           Biopotential      2
                                       amplifier and
                                       signal
                                       conditioner
                   870.2060           Transducer        2
                                       signal
                                       amplifier and
                                       conditioner
                   870.2100           Cardiovascular    2
                                       blood flow-
                                       meter
                   870.2120           Extravascular     2
                                       blood flow
                                       probe
                   870.2300           Cardiac monitor   2
                                       (including
                                       cardiotachomete
                                       r and rate
                                       alarm)
                   870.2700           Oximeter          2
                   870.2710           Ear oximeter      2
                   870.2750           Impedance         2
                                       phlebograph
                   870.2770           Impedance         2
                                       plethysmograph
                   870.2780           Hydraulic,        2
                                       pneumatic, or
                                       photoelectric
                                       plethysmographs
                   870.2850           Extravascular     2
                                       blood pressure
                                       transducer
                   870.2870           Catheter tip      2
                                       pressure
                                       transducer
                   870.2880           Ultrasonic        2
                                       transducer
                   870.2890           Vessel occlusion  2
                                       transducer
                   870.2900           Patient           2
                                       transducer and
                                       electrode cable
                                       (including
                                       connector)
                   870.2910           Radiofrequency    2
                                       physiological
                                       signal
                                       transmitter and
                                       receiver
                   870.2920           Telephone         2
                                       electrocardiogr
                                       aph transmitter
                                       and receiver
                   870.4205           Cardiopulmonary   2
                                       bypass bubble
                                       detector
                   870.4220           Cardiopulmonary   2
                                       bypass heart-
                                       lung machine
                                       console
                   870.4240           Cardiovascular    2
                                       bypass heat
                                       exchanger
                   870.4250           Cardiopulmonary   2
                                       bypass
                                       temperature
                                       controller
                   870.4300           Cardiopulmonary   2
                                       bypass gas
                                       control unit
                   870.4310           Cardiopulmonary   2
                                       bypass coronary
                                       pressure gauge
                   870.4330           Cardiopulmonary   2
                                       bypass on-line
                                       blood gas
                                       monitor
                   870.4340           Cardiopulmonary   2
                                       bypass level
                                       sensing monitor
                                       and/or control
                   870.4370           Roller-type       2
                                       cardiopulmonary
                                       bypass blood
                                       pump
                   870.4380           Cardiopulmonary   2
                                       bypass pump
                                       speed control
                   870.4410           Cardiopulmonary   2
                                       bypass in-line
                                       blood gas
                                       sensor
    Cardiovascula  870.5050           Patient care      2
     r                                 suction
     Therapeutic                       apparatus
                   870.5900           Thermal           2
                                       regulation
                                       system
    Defibrillator  870.5300           DC-defibrillator  2
                                       (including
                                       paddles)
                   870.5325           Defibrillator     2
                                       tester
    Echocardiogra  870.2330           Echocardiograph   2
     ph
    Pacemaker &    870.1750           External          2
     Accessories                       programmable
                                       pacemaker pulse
                                       generator
                   870.3630           Pacemaker         2
                                       generator
                                       function
                                       analyzer

[[Page 60156]]

                   870.3640           Indirect          2
                                       pacemaker
                                       generator
                                       function
                                       analyzer
                   870.3720           Pacemaker         2
                                       electrode
                                       function tester
    Miscellaneous  870.1800           Withdrawal-       2
                                       infusion pump
                   870.2800           Medical magnetic  2
                                       tape recorder
                   None               Batteries,
                                       rechargeable,
                                       class II
                                       devices
Dental Panel
    Dental         872.1720           Pulp tester       2
     Equipment
                   872.1740           Caries detection  2
                                       device
                   872.4120           Bone cutting      2
                                       instrument and
                                       accessories
                   872.4465           Gas-powered jet   2
                                       injector
                   872.4475           Spring-powered    2
                                       jet injector
                   872.4600           Intraoral         2
                                       ligature and
                                       wire lock
                   872.4840           Rotary scaler     2
                   872.4850           Ultrasonic        2
                                       scaler
                   872.4920           Dental            2
                                       electrosurgical
                                       unit and
                                       accessories
                   872.6070           Ultraviolet       2
                                       activator for
                                       polymerization
                   872.6350           Ultraviolet       2
                                       detector
    Dental         872.3050           Amalgam alloy     2
     Material
                   872.3060           Gold-based        2
                                       alloys and
                                       precious metal
                                       alloys for
                                       clinical use
                   872.3200           Resin tooth       2
                                       bonding agent
                   872.3250           Calcium           2
                                       hydroxide
                                       cavity liner
                   872.3260           Cavity varnish    2
                   872.3275           Dental cement     2
                                       (other than
                                       zinc oxide-
                                       eugenol)
                   872.3300           Hydrophilic       2
                                       resin coating
                                       for dentures
                   872.3310           Coating material  2
                                       for resin
                                       fillings
                   872.3590           Preformed         2
                                       plastic denture
                                       tooth
                   872.3660           Impression        2
                                       material
                   872.3690           Tooth shade       2
                                       resin material
                   872.3710           Base metal alloy  2
                   872.3750           Bracket adhesive  2
                                       resin and tooth
                                       conditioner
                   872.3760           Denture           2
                                       relining,
                                       repairing, or
                                       rebasing resin
                   872.3765           Pit and fissure   2
                                       sealant and
                                       conditioner
                   872.3770           Temporary crown   2
                                       and bridge
                                       resin
                   872.3820           Root canal        2
                                       filling resin
                                       (other than
                                       chloroform use)
                   872.3920           Porcelain tooth   2
    Dental X-ray   872.1800           Extraoral source  2
                                       x-ray system
                   872.1810           Intraoral source  2
                                       x-ray system
     Dental        872.4880           Intraosseous      2
     Implants                          fixation screw
                                       or wire
                   872.3890           Endodontic        2
                                       stabilizing
                                       splint
    Orthodontic    872.5470           Orthodontic       2
                                       plastic bracket
Ear/Nose/Throat
 Panel
    Diagnostic     874.1050           Audiometer        2
     Equipment
                   874.1090           Auditory          2
                                       impedance
                                       tester
                   874.1120           Electronic noise  2
                                       generator for
                                       audiometric
                                       testing
                   874.1325           Electroglottogra  2
                                       ph
                   874.1820           Surgical nerve    2
                                       stimulator/
                                       locator
    Hearing Aids   874.3300           Hearing aid (for  2
                                       bone-
                                       conduction)
                   874.3310           Hearing aid       2
                                       calibrator and
                                       analysis system
                   874.3320           Group hearing     2
                                       aid or group
                                       auditory
                                       trainer
                   874.3330           Master hearing    2
                                       aid
    Surgical       874.4250           Ear, nose, and    1
     Equipment                         throat electric
                                       or pneumatic
                                       surgical drill
                   874.4490           Argon laser for   2
                                       otology,
                                       rhinology, and
                                       laryngology

[[Page 60157]]

                   874.4500           Ear, nose, and    2
                                       throat
                                       microsurgical
                                       carbon dioxide
                                       laser
Gastroenterology/
 Urology Panel
    Endoscope      876.1500           Endoscope and     2
     (including                        accessories
     angioscopes,
     laparscopes,
     ophthalmic
     endoscopes)
                   876.4300           Endoscopic        2
                                       electrosurgical
                                       unit and
                                       accessories
    Gastroenterol  876.1725           Gastrointestinal  1
     ogy                               motility
                                       monitoring
                                       system
    Hemodialysis   876.5600           Sorbent           2
                                       regenerated
                                       dialysate
                                       delivery system
                                       for
                                       hemodialysis
                   876.5630           Peritoneal        2
                                       dialysis system
                                       and accessories
                   876.5665           Water             2
                                       purification
                                       system for
                                       hemodialysis
                   876.5820            Hemodialysis     2
                                       system and
                                       accessories
                   876.5830           Hemodialyzer      2
                                       with disposable
                                       insert (kiil-
                                       type)
    Lithotriptor   876.4500           Mechanical        2
                                       lithotriptor
    Urology        876.1620           Urodynamics       2
     Equipment                         measurement
                                       system
                   876.5320           Nonimplanted      2
                                       electrical
                                       continence
                                       device
                   876.5880           Isolated kidney   2
                                       perfusion and
                                       transport
                                       system and
                                       accessories
General Hospital
 Panel
    Infusion       880.2420           Electronic        2
     Pumps and                         monitor for
     Systems                           gravity flow
                                       infusion
                                       systems
                   880.2460           Electrically      2
                                       powered spinal
                                       fluid pressure
                                       monitor
                   880.5430           Nonelectrically   2
                                       powered fluid
                                       injector
                   880.5725           Infusion pump     2
    Neonatal       880.5400           Neonatal          2
     Incubators                        incubator
                   880.5410           Neonatal          2
                                       transport
                                       incubator
                   880.5700           Neonatal          2
                                       phototherapy
                                       unit
    Piston         880.5570           Hypodermic        1
     Syringes                          single lumen
                                       needle
                   880.5860           Piston syringe    1
                                       (except
                                       antistick)
                   880.6920           Syringe needle    2
                                       introducer
    Miscellaneous  880.2910           Clinical          2
                                       electronic
                                       thermometer
                   880.2920           Clinical mercury  2
                                       thermometer
                   880.5100           AC-powered        1
                                       adjustable
                                       hospital bed
                   880.5500           AC-powered        2
                                       patient lift
                   880.6880           Steam sterilizer  2
                                       (greater than 2
                                       cubic feet)
Neurology Panel
                   882.1020           Rigidity          2
                                       analyzer
                   882.1610           Alpha monitor     2
    Neuro-         882.1320           Cutaneous         2
     Diagnostic                        electrode
                   882.1340           Nasopharyngeal    2
                                       electrode
                   882.1350           Needle electrode  2
                   882.1400           Electroencephalo  2
                                       graph
                   882.1460           Nystagmograph     2
                   882.1480           Neurological      2
                                       endoscope
                   882.1540           Galvanic skin     2
                                       response
                                       measurement
                                       device
                   882.1550           Nerve conduction  2
                                       velocity
                                       measurement
                                       device
                   882.1560           Skin potential    2
                                       measurement
                                       device
                   882.1570           Powered direct-   2
                                       contact
                                       temperature
                                       measurement
                                       device
                   882.1620           Intracranial      2
                                       pressure
                                       monitoring
                                       device
                   882.1835           Physiological     2
                                       signal
                                       amplifier
                   882.1845           Physiological     2
                                       signal
                                       conditioner

[[Page 60158]]

                   882.1855           Electroencephalo  2
                                       gram (EEG)
                                       telemetry
                                       system
                   882.5050           Biofeedback       2
                                       device
    Echoencephalo  882.1240           Echoencephalogra  2
     graphy                            ph
    RPG            882.4400           Radiofrequency    2
                                       lesion
                                       generator
    Neuro Surgery  none               Electrode,        2
                                       spinal epidural
                   882.4305           Powered compound  2
                                       cranial drills,
                                       burrs,
                                       trephines, and
                                       their
                                       accessories
                   882.4310           Powered simple    2
                                       cranial drills
                                       burrs,
                                       trephines, and
                                       their
                                       accessories
                   882.4360           Electric cranial  2
                                       drill motor
                   882.4370           Pneumatic         2
                                       cranial drill
                                       motor
                   882.4560           Stereotaxic       2
                                       instrument
                   882.4725           Radiofrequency    2
                                       lesion probe
                   882.4845           Powered rongeur   2
                   882.5500           Lesion            2
                                       temperature
                                       monitor
    Stimulators    882.1870           Evoked response   2
                                       electrical
                                       stimulator
                   882.1880           Evoked response   2
                                       mechanical
                                       stimulator
                   882.1890           Evoked response   2
                                       photic
                                       stimulator
                   882.1900           Evoked response   2
                                       auditory
                                       stimulator
                   882.1950           Tremor            2
                                       transducer
                   882.5890           Transcutaneous    2
                                       electrical
                                       nerve
                                       stimulator for
                                       pain relief
Obstetrics/
 Gynecology Panel
    Fetal          884.1660           Transcervical     2
     Monitoring                        endoscope
                                       (amnioscope)
                                       and accessories
                   884.1690           Hysteroscope and  2
                                       accessories
                                       (for
                                       performance
                                       standards)
                   884.2225           Obstetric-        2
                                       gynecologic
                                       ultrasonic
                                       imager
                   884.2600           Fetal cardiac     2
                                       monitor
                   884.2640           Fetal             2
                                       phonocardiograp
                                       hic monitor and
                                       accessories
                   884.2660           Fetal ultrasonic  2
                                       monitor and
                                       accessories
                   884.2675           Fetal scalp       1
                                       circular
                                       (spiral)
                                       electrode and
                                       applicator
                   884.2700           Intrauterine      2
                                       pressure
                                       monitor and
                                       accessories
                   884.2720           External uterine  2
                                       contraction
                                       monitor and
                                       accessories
                   884.2740           Perinatal         2
                                       monitoring
                                       system and
                                       accessories
                   884.2960           Obstetric         2
                                       ultrasonic
                                       transducer and
                                       accessories
    Gynecological  884.1720           Gynecologic       2
     Surgery                           laparoscope and
     Equipment                         accessories
                   884.4160           Unipolar          2
                                       endoscopic
                                       coagulator-
                                       cutter and
                                       accessories
                   884.4550           Gynecologic       2
                                       surgical laser
                   884.4120           Gynecologic       2
                                       electrocautery
                                       and accessories
                   884.5300           Condom            2
    Ophthalmic     886.3320           Eye sphere        2
     Implants                          implant
    Contact Lens   886.1385           Polymethylmethac  2
                                       rylate (PMMA)
                                       diagnostic
                                       contact lens
                   886.5916           Rigid gas         2
                                       permeable
                                       contact lens
                                       (daily wear
                                       only)
    Diagnostic     886.1120           Opthalmic camera  1
     Equipment
                   886.1220           Corneal           1
                                       electrode
                   886.1250           Euthyscope (AC-   1
                                       powered)
                   886.1360           Visual field      1
                                       laser
                                       instrument
                   886.1510           Eye movement      1
                                       monitor
                   886.1570           Ophthalmoscope    1
                   886.1630           AC-powered        1
                                       photostimulator
                   886.1640           Ophthalmic        1
                                       preamplifier

[[Page 60159]]

                   886.1670           Ophthalmic        2
                                       isotope uptake
                                       probe
                   886.1780           Retinoscope (AC-  1
                                       powered device)
                   886.1850           AC-powered slit   1
                                       lamp
                                       biomicroscope
                   886.1930           Tonometer and     2
                                       accessories
                   886.1945           Transilluminator  1
                                       (AC-powered
                                       device)
                   886.3130           Ophthalmic        2
                                       conformer
    (Diagnostic/   886.4670           Phacofragmentati  2
     Surgery                           on system
     Equipment)
     Ophthalmic    886.3340           Extraocular       2
     Implants                          orbital implant
                   886.3800           Scleral shell     2
    Surgical        880.5725          Infusion pump     2
     Equipment                         (performance
                                       standards)
                   886.3100           Ophthalmic        2
                                       tantalum clip
                   886.3300           Absorbable        2
                                       implant
                                       (scleral
                                       buckling
                                       method)
                   886.4100           Radiofrequency    2
                                       electrosurgical
                                       cautery
                                       apparatus
                   886.4115           Thermal cautery   2
                                       unit
                   886.4150           Vitreous          2
                                       aspiration and
                                       cutting
                                       instrument
                   886.4170           Cryophthalmic     2
                                       unit
                   886.4250           Ophthalmic        1
                                       electrolysis
                                       unit (AC-
                                       powered device)
                   886.4335           Operating         1
                                       headlamp (AC-
                                       powered device)
                   886.4390           Ophthalmic laser  2
                   886.4392           Nd:YAG laser for  2
                                       posterior
                                       capsulotomy
                   886.4400           Electronic metal  1
                                       locator
                   886.4440           AC-powered        1
                                       magnet
                   886.4610           Ocular pressure   2
                                       applicator
                   886.4690           Ophthalmic        2
                                       photocoagulator
                   886.4790           Ophthalmic        2
                                       sponge
                   886.5100           Ophthalmic beta   2
                                       radiation
                                       source
                   none               Ophthalmoscopes,  1
                                       replacement
                                       batteries, hand-
                                       held
Orthopedic Panel
    Implants       888.3010           Bone fixation     2
                                       cerclage
                   888.3020           Intramedullary    2
                                       fixation rod
                   888.3030           Single/multiple   2
                                       component
                                       metallic bone
                                       fixation
                                       appliances and
                                       accessories
                   888.3040           Smooth or         2
                                       threaded
                                       metallic bone
                                       fixation
                                       fastener
                   888.3050           Spinal            2
                                       interlaminal
                                       fixation
                                       orthosis
                   888.3060           Spinal            2
                                       intervertebral
                                       body fixation
                                       orthosis
    Surgical       888.1240           AC-powered        2
     Equipment                         dynamometer
                   888.4580           Sonic surgical    2
                                       instrument and
                                       accessories/
                                       attachments
                   none               Accessories,      2
                                       fixation,
                                       spinal
                                       interlaminal
                   none               Accessories,      2
                                       fixation,
                                       spinal
                                       intervertebral
                                       body
                   none               Monitor,          1
                                       pressure,
                                       intracompartmen
                                       tal
                   none               Orthosis,         2
                                       fixation,
                                       spinal
                                       intervertebral
                                       fusion
                   none               Orthosis, spinal
                                       pedicle
                                       fixation
                   none               System, cement    1
                                       removal
                                       extraction
Physical Medicine
 Panel
    Diagnostic     890.1225           Chronaximeter     2
     Equipment or
     (Therapy)
     Therapeutic
     Equipment
                   890.1375           Diagnostic        2
                                       electromyograph
                   890.1385           Diagnostic        2
                                       electromyograph
                                       needle
                                       electrode

[[Page 60160]]

                   890.1450           Powered reflex    2
                                       hammer
                   890.1850           Diagnostic        2
                                       muscle
                                       stimulator
    or (Therapy)   890.5850           Powered muscle    2
                                       stimulator
    Therapeutic    890.5100           Immersion         2
     Equipment                         hydrobath
                   890.5110           Paraffin bath     2
                   890.5500           Infrared lamp     2
                   890.5720           Water             2
                                       circulating hot
                                       or cold pack
                   890.5740           Powered heating   2
                                       pad
Radiology Panel
    MRI            892.1000           Magnetic          2
                                       resonance
                                       diagnostic
                                       device
    Ultrasound     884.2660           Fetal ultrasonic  2
     Diagnostic                        monitor and
                                       accessories
                   892.1540           Nonfetal
                                       ultrasonic
                                       monitor
                   892.1560           Ultrasonic        2
                                       pulsed echo
                                       imaging system
                   892.1570           Diagnostic        2
                                       ultrasonic
                                       transducer
                   892.1550           Ultrasonic
                                       pulsed doppler
                                       imaging system
    Angiographic   892.1600           Angiographic x-   2
                                       ray system
    Diagnostic X-  892.1610           Diagnostic x-ray  2
     Ray                               beam-limiting
                                       device
                   892.1620           Cine or spot      2
                                       fluorographic x-
                                       ray camera
                   892.1630           Electrostatic x-  2
                                       ray imaging
                                       system
                   892.1650           Image-            2
                                       intensified
                                       fluoroscopic x-
                                       ray system
                   892.1670           Spot film device  2
                   892.1680           Stationary x-ray  2
                                       system
                   892.1710           Mammographic x-   2
                                       ray system
                   892.1720           Mobile x-ray      2
                                       system
                   892.1740           Tomographic x-    1
                                       ray system
                   892.1820           Pneumoencephalog  2
                                       raphic chair
                   892.1850           Radiographic      1
                                       film cassette
                   892.1860           Radiographic      1
                                       film/cassette
                                       changer
                   892.1870           Radiographic      2
                                       film/cassette
                                       changer
                                       programmer
                   892.1900           Automatic         2
                                       radiographic
                                       film processor
                   892.1980           Radiologic table  1
    CT Scanner     892.1750           Computed          2
                                       tomography x-
                                       ray system
    Radiation      892.5050           Medical charged-  2
     Therapy                           particle
                                       radiation
                                       therapy system
                   892.5300           Medical neutron   2
                                       radiation
                                       therapy system
                   892.5700           Remote            2
                                       controlled
                                       radionuclide
                                       applicator
                                       system
                   892.5710           Radiation         2
                                       therapy beam-
                                       shaping block
                   892.5730           Radionuclide      2
                                       brachytherapy
                                       source
                   892.5750           Radionuclide      2
                                       radiation
                                       therapy system
                   892.5770           Powered           2
                                       radiation
                                       therapy patient
                                       support
                                       assembly
                   892.5840           Radiation         2
                                       therapy
                                       simulation
                                       system
                   892.5930           Therapeutic x-    1
                                       ray tube
                                       housing
                                       assembly
    Nuclear        892.1170           Bone              2
     Medicine                          densitometer
                   892.1200           Emission          2
                                       computed
                                       tomography
                                       system
                   892.1310           Nuclear           1
                                       tomography
                                       system
                   892.1390           Radionuclide      2
                                       rebreathing
                                       system
General/Plastic
 Surgery Panel
    Surgical       878.4630           Ultraviolet lamp  2
     Lamps                             for
                                       dermatologic
                                       disorders
                   890.5500           Infrared lamp     2
                   878.4580           Surgical lamp     2

[[Page 60161]]

    Electrosurgic  878.4810           Laser surgical    2
     al Cutting                        instrument for
     Equipment                         use in general
                                       and plastic
                                       surgery and in
                                       dermatology
                   878.4400           Electrosurgical   2
                                       cutting and
                                       coagulation
                                       device and
                                       accessories
    Miscellaneous  878.4780           Powered suction   2
                                       pump
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other
  medical device identifiers may be viewed on FDA's Internet Web Site at
  ``http://www.fda.gov/cdrh/prodcode.html''.

Appendix C of Subpart B [Reserved].

Appendix D of Subpart B [Reserved].

Appendix E of Subpart B [Reserved].

Appendix F of Subpart B [Reserved].

Subpart C--``Framework'' Provisions


Sec. 26.60   Definitions.

     (a) The following terms and definitions shall apply to this 
subpart only:
     (1) Designating Authority means a body with power to designate, 
monitor, suspend, remove suspension of, or withdraw conformity 
assessment bodies as specified under this part.
     (2) Designation means the identification by a designating 
authority of a conformity assessment body to perform conformity 
assessment procedures under this part.
     (3) Regulatory Authority means a government agency or entity that 
exercises a legal right to control the use or sale of products within a 
party's jurisdiction and may take enforcement action to ensure that 
products marketed within its jurisdiction comply with legal 
requirements.
     (b) Other terms concerning conformity assessment used in this part 
shall have the meaning given elsewhere in this part or in the 
definitions contained in ``Guide 2: Standardization and Related 
Activities--General Vocabulary of the International Organization for 
Standardization (ISO) and the International Electrotechnical Commission 
(IEC)'' (ISO/IEC Guide 2) (1996 edition), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
are available from the International Organization for Standardization, 
1, rue de Varembe, Case postale 56, CH-1211 Geneve 20, Switzerland, or 
on the Internet at ``http://www.iso.ch'' or may be examined at the Food 
and Drug Administration's Medical Library, 5600 Fishers Lane, rm. 11B-
40, Rockville, MD 20857, or the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC. In the event of an 
inconsistency between the ISO/IEC Guide 2 and definitions in this part, 
the definitions in this part shall prevail.


Sec. 26.61   Purpose of this part.

    This part specifies the conditions by which each party will accept 
or recognize results of conformity assessment procedures, produced by 
the other party's conformity assessment bodies (CAB's) or authorities, 
in assessing conformity to the importing party's requirements, as 
specified on a sector-specific basis in subparts A and B of this part, 
and to provide for other related cooperative activities. The objective 
of such mutual recognition is to provide effective market access 
throughout the territories of the parties with regard to conformity 
assessment for all products covered under this part. If any obstacles 
to such access arise, consultations will promptly be held. In the 
absence of a satisfactory outcome of such consultations, the party 
alleging its market access has been denied may, within 90 days of such 
consultation, invoke its right to terminate the ``Agreement on Mutual 
Recognition Between the United States of America and the European 
Community,'' from which this part is derived, in accordance with 
Sec. 26.80.


Sec. 26.62   General obligations.

     (a) The United States shall, as specified in subparts A and B of 
this part, accept or recognize results of specified procedures, used in 
assessing conformity to specified legislative, regulatory, and 
administrative provisions of the United States, produced by the other 
party's conformity assessment bodies (CAB's) and/or authorities.
     (b) The European Community (EC) and its Member States shall, as 
specified in subparts A and B of this part, accept or recognize results 
of specified procedures, used in assessing conformity to specified 
legislative, regulatory, and administrative provisions of the EC and 
its Member States, produced by the other party's CAB's and/or 
authorities.
     (c) Where sectoral transition arrangements have been specified in 
subparts A and B of this part, the obligations in paragraphs (a) and 
(b) of this section will apply following the successful completion of 
those sectoral transition arrangements, with the understanding that the 
conformity assessment procedures utilized assure conformity to the 
satisfaction of the receiving party, with applicable legislative, 
regulatory, and administrative provisions of that party, equivalent to 
the assurance offered by the receiving party's own procedures.


Sec. 26.63   General coverage of this part.

     (a) This part applies to conformity assessment procedures for 
products and/or processes and to other related cooperative activities 
as described in this part.
     (b) Subparts A and B of this part may include:
     (1) A description of the relevant legislative, regulatory, and 
administrative provisions pertaining to the conformity assessment 
procedures and technical regulations;
     (2) A statement on the product scope and coverage;
     (3) A list of designating authorities;
     (4) A list of agreed conformity assessment bodies (CAB's) or 
authorities or a source from which to obtain a list of such bodies or 
authorities and a statement of the scope of the conformity assessment 
procedures for which each has been agreed;
     (5) The procedures and criteria for designating the CAB's;
     (6) A description of the mutual recognition obligations;
     (7) A sectoral transition arrangement;
     (8) The identity of a sectoral contact point in each party's 
territory; and
     (9) A statement regarding the establishment of a Joint Sectoral 
Committee.
     (c) This part shall not be construed to entail mutual acceptance 
of standards or technical regulations of the parties and, unless 
otherwise specified in subpart A or B of this part, shall not entail 
the

[[Page 60162]]

mutual recognition of the equivalence of standards or technical 
regulations.


Sec. 26.64   Transitional arrangements.

     The parties agree to implement the transitional commitments on 
confidence building as specified in subparts A and B of this part.
     (a) The parties agree that each sectoral transitional arrangement 
shall specify a time period for completion.
     (b) The parties may amend any transitional arrangement by mutual 
agreement.
     (c) Passage from the transitional phase to the operational phase 
shall proceed as specified in subparts A and B of this part, unless 
either party documents that the conditions provided in such subpart for 
a successful transition are not met.


Sec. 26.65   Designating authorities.

     The parties shall ensure that the designating authorities 
specified in subpart B of this part have the power and competence in 
their respective territories to carry out decisions under this part to 
designate, monitor, suspend, remove suspension of, or withdraw 
conformity assessment bodies (CAB's).


Sec. 26.66   Designation and listing procedures.

     The following procedures shall apply with regard to the 
designation of conformity assessment bodies (CAB's) and the inclusion 
of such bodies in the list of CAB's in subpart B of this part:
     (a) The designating authority identified in subpart B of this part 
shall designate CAB's in accordance with the procedures and criteria 
set forth in subpart B of this part;
     (b) A party proposing to add a CAB to the list of such bodies in 
subpart B of this part shall forward its proposal of one or more 
designated CAB's in writing to the other party with a view to a 
decision by the Joint Committee;
     (c) Within 60 days following receipt of the proposal, the other 
party shall indicate its position regarding either its confirmation or 
its opposition. Upon confirmation, the inclusion in subpart B of this 
part of the proposed CAB or CAB's shall take effect; and
     (d) In the event that the other party contests on the basis of 
documented evidence the technical competence or compliance of a 
proposed CAB, or indicates in writing that it requires an additional 30 
days to more fully verify such evidence, such CAB shall not be included 
on the list of CAB's in subpart B of this part. In this instance, the 
Joint Committee may decide that the body concerned be verified. After 
the completion of such verification, the proposal to list the CAB in 
subpart B may be resubmitted to the other party.


Sec. 26.67   Suspension of listed conformity assessment bodies.

     The following procedures shall apply with regard to the suspension 
of a conformity assessment body (CAB) listed in subpart B of this part.
     (a) A party shall notify the other party of its contestation of 
the technical competence or compliance of a CAB listed in subpart B of 
this part and the contesting party's intent to suspend such CAB. Such 
contestation shall be exercised when justified in an objective and 
reasoned manner in writing to the other party;
     (b) The CAB shall be given prompt notice by the other party and an 
opportunity to present information in order to refute the contestation 
or to correct the deficiencies which form the basis of the 
contestation;
     (c) Any such contestation shall be discussed between the parties 
in the Joint Sectoral Committee described in subpart B of this part. If 
there is no Joint Sectoral Committee, the contesting party shall refer 
the matter directly to the Joint Committee. If agreement to suspend is 
reached by the Joint Sectoral Committee or, if there is no Joint 
Sectoral Committee, by the Joint Committee, the CAB shall be suspended;
     (d) Where the Joint Sectoral Committee or Joint Committee decides 
that verification of technical competence or compliance is required, it 
shall normally be carried out in a timely manner by the party in whose 
territory the body in question is located, but may be carried out 
jointly by the parties in justified cases;
     (e) If the matter has not been resolved by the Joint Sectoral 
Committee within 10 days of the notice of contestation, the matter 
shall be referred to the Joint Committee for a decision. If there is no 
Joint Sectoral Committee, the matter shall be referred directly to the 
Joint Committee. If no decision is reached by the Joint Committee 
within 10 days of the referral to it, the CAB shall be suspended upon 
the request of the contesting party;
     (f) Upon the suspension of a CAB listed in subpart B of this part, 
a party is no longer obligated to accept or recognize the results of 
conformity assessment procedures performed by that CAB subsequent to 
suspension. A party shall continue to accept the results of conformity 
assessment procedures performed by that CAB prior to suspension, unless 
a regulatory authority of the party decides otherwise based on health, 
safety or environmental considerations or failure to satisfy other 
requirements within the scope of subpart B of this part; and
     (g) The suspension shall remain in effect until agreement has been 
reached by the parties upon the future status of that body.


Sec. 26.68   Withdrawal of listed conformity assessment bodies.

     The following procedures shall apply with regard to the withdrawal 
from subpart B of this part of a conformity assessment body (CAB):
     (a) A party proposing to withdraw a CAB listed in subpart B of 
this part shall forward its proposal in writing to the other party;
     (b) Such CAB shall be promptly notified by the other party and 
shall be provided a period of at least 30 days from receipt to provide 
information in order to refute or to correct the deficiencies which 
form the basis of the proposed withdrawal;
     (c) Within 60 days following receipt of the proposal, the other 
party shall indicate its position regarding either its confirmation or 
its opposition. Upon confirmation, the withdrawal from the list in 
subpart B of this part of the CAB shall take effect;
     (d) In the event the other party opposes the proposal to withdraw 
by supporting the technical competence and compliance of the CAB, the 
CAB shall not at that time be withdrawn from the list of CAB's in 
subpart B of this part. In this instance, the Joint Sectoral Committee 
or the Joint Committee may decide to carry out a joint verification of 
the body concerned. After the completion of such verification, the 
proposal for withdrawal of the CAB may be resubmitted to the other 
party; and
     (e) Subsequent to the withdrawal of a CAB listed in subpart B of 
this part, a party shall continue to accept the results of conformity 
assessment procedures performed by that CAB prior to withdrawal, unless 
a regulatory authority of the party decides otherwise based on health, 
safety, and environmental considerations or failure to satisfy other 
requirements within the scope of subpart B of this part.


Sec. 26.69   Monitoring of conformity assessment bodies.

     The following shall apply with regard to the monitoring of 
conformity assessment bodies (CAB's) listed in subpart B of this part:
     (a) Designating authorities shall assure that their CAB's listed 
in subpart B of this part are capable and remain capable of properly 
assessing conformity of products or processes, as applicable, and as 
covered in subpart B of this part. In this regard, designating 
authorities shall maintain, or cause to maintain, ongoing surveillance 
over

[[Page 60163]]

their CAB's by means of regular audit or assessment;
     (b) The parties undertake to compare methods used to verify that 
the CAB's listed in subpart B of this part comply with the relevant 
requirements of subpart B of this part. Existing systems for the 
evaluation of CAB's may be used as part of such comparison procedures;
     (c) Designating authorities shall consult as necessary with their 
counterparts, to ensure the maintenance of confidence in conformity 
assessment procedures. With the consent of both parties, this 
consultation may include joint participation in audits/inspections 
related to conformity assessment activities or other assessments of 
CAB's listed in subpart B of this part; and
     (d) Designating authorities shall consult, as necessary, with the 
relevant regulatory authorities of the other party to ensure that all 
technical requirements are identified and are satisfactorily addressed.


Sec. 26.70   Conformity assessment bodies.

     Each party recognizes that the conformity assessment bodies 
(CAB's) listed in subpart B of this part fulfill the conditions of 
eligibility to assess conformity in relation to its requirements as 
specified in subpart B of this part. The parties shall specify the 
scope of the conformity assessment procedures for which such bodies are 
listed.


Sec. 26.71   Exchange of information.

     (a) The parties shall exchange information concerning the 
implementation of the legislative, regulatory, and administrative 
provisions identified in subparts A and B of this part.
     (b) Each party shall notify the other party of legislative, 
regulatory, and administrative changes related to the subject matter of 
this part at least 60 days before their entry into force. Where 
considerations of safety, health or environmental protection require 
more urgent action, a party shall notify the other party as soon as 
practicable.
     (c) Each party shall promptly notify the other party of any 
changes to its designating authorities and/or conformity assessment 
bodies (CAB's).
     (d) The parties shall exchange information concerning the 
procedures used to ensure that the listed CAB's under their 
responsibility comply with the legislative, regulatory, and 
administrative provisions outlined in subpart B of this part.
     (e) Regulatory authorities identified in subparts A and B of this 
part shall consult as necessary with their counterparts, to ensure the 
maintenance of confidence in conformity assessment procedures and to 
ensure that all technical requirements are identified and are 
satisfactorily addressed.


Sec. 26.72   Sectoral contact points.

     Each party shall appoint and confirm in writing contact points to 
be responsible for activities under subparts A and B of this part.


Sec. 26.73   Joint Committee.

     (a) A Joint Committee consisting of representatives of the United 
States and the European Community (EC) will be established. The Joint 
Committee shall be responsible for the effective functioning of the 
``Agreement on Mutual Recognition Between the United States of America 
and the European Community,'' from which this part is derived.
     (b) The Joint Committee may establish Joint Sectoral Committees 
comprised of appropriate regulatory authorities and others deemed 
necessary.
     (c) The United States and the EC shall each have one vote in the 
Joint Committee. The Joint Committee shall make its decisions by 
unanimous consent. The Joint Committee shall determine its own rules 
and procedures.
     (d) The Joint Committee may consider any matter relating to the 
effective functioning of that agreement. In particular it shall be 
responsible for:
     (1) Listing, suspension, withdrawal and verification of conformity 
assessment bodies (CAB's) in accordance with that agreement;
     (2) Amending transitional arrangements in the sectoral annexes to 
that agreement;
     (3) Resolving any questions relating to the application of that 
agreement not otherwise resolved in the respective Joint Sectoral 
Committees;
     (4) Providing a forum for discussion of issues that may arise 
concerning the implementation of that agreement;
     (5) Considering ways to enhance the operation of that agreement;
     (6) Coordinating the negotiation of additional sectoral annexes to 
that agreement; and
     (7) Considering whether to amend that agreement in accordance with 
Sec. 26.80.
     (e) When a party introduces new or additional conformity 
assessment procedures affecting a sectoral annex to that agreement, the 
parties shall discuss the matter in the Joint Committee with a view to 
bringing such new or additional procedures within the scope of that 
agreement and the relevant sectoral annex.


Sec. 26.74   Preservation of regulatory authority.

     (a) Nothing in this part shall be construed to limit the authority 
of a party to determine, through its legislative, regulatory, and 
administrative measures, the level of protection it considers 
appropriate for safety; for protection of human, animal, or plant life 
or health; for the environment; for consumers; and otherwise with 
regard to risks within the scope of the applicable subpart A or B of 
this part.
     (b) Nothing in this part shall be construed to limit the authority 
of a regulatory authority to take all appropriate and immediate 
measures whenever it ascertains that a product may:
     (1) Compromise the health or safety of persons in its territory;
     (2) Not meet the legislative, regulatory, or administrative 
provisions within the scope of the applicable subpart A or B of this 
part; or
     (3) Otherwise fail to satisfy a requirement within the scope of 
the applicable subpart A or B of this part. Such measures may include 
withdrawing the products from the market, prohibiting their placement 
on the market, restricting their free movement, initiating a product 
recall, and preventing the recurrence of such problems, including 
through a prohibition on imports. If the regulatory authority takes 
such action, it shall inform its counterpart authority and the other 
party within 15 days of taking such action, providing its reasons.


Sec. 26.75   Suspension of recognition obligations.

     Either party may suspend its obligations under subpart A or B of 
this part, in whole or in part, if:
     (a) A party suffers a loss of market access for the party's 
products within the scope of subpart A or B of this part as a result of 
the failure of the other party to fulfill its obligations under this 
part;
     (b) The adoption of new or additional conformity assessment 
requirements as referenced in Sec. 26.73(e) results in a loss of market 
access for the party's products within the scope of subpart B of this 
part because conformity assessment bodies (CAB's) designated by the 
party in order to meet such requirements have not been recognized by 
the party implementing the requirements; or
     (c) The other party fails to maintain legal and regulatory 
authorities capable of implementing the provisions of this part.

[[Page 60164]]

Sec. 26.76   Confidentiality.

     (a) Each party agrees to maintain, to the extent required under 
its laws, the confidentiality of information exchanged under this part.
     (b) In particular, neither party shall disclose to the public, nor 
permit a conformity assessment body (CAB) to disclose to the public, 
information exchanged under this part that constitutes trade secrets, 
confidential commercial or financial information, or information that 
relates to an ongoing investigation.
     (c) A party or a CAB may, upon exchanging information with the 
other party or with a CAB of the other party, designate the portions of 
the information that it considers to be exempt from disclosure.
     (d) Each party shall take all precautions reasonably necessary to 
protect information exchanged under this part from unauthorized 
disclosure.


Sec. 26.77   Fees.

     Each party shall endeavor to ensure that fees imposed for services 
under this part shall be commensurate with the services provided. Each 
party shall ensure that, for the sectors and conformity assessment 
procedures covered under this part, it shall charge no fees with 
respect to conformity assessment services provided by the other party.


Sec. 26.78   Agreements with other countries.

     Except where there is written agreement between the parties, 
obligations contained in mutual recognition agreements concluded by 
either party with a party not a party to the agreement from which this 
part is derived (a third party) shall have no force and effect with 
regard to the other party in terms of acceptance of the results of 
conformity assessment procedures in the third party.


Sec. 26.79   Territorial application.

     The agreement from which this part is derived shall apply, on the 
one hand, to the territories in which the Treaty establishing the 
European Community (EC) is applied, and under the conditions laid down 
in that Treaty and, on the other hand, to the territory of the United 
States.


Sec. 26.80   Entry into force, amendment, and termination.

     (a) The ``Agreement on Mutual Recognition Between the United 
States of America and the European Community,'' from which this part is 
derived, including its sectoral annexes on telecommunication equipment, 
electromagnetic compatibility, electrical safety, recreational craft, 
pharmaceutical Good Manufacturing Practices (GMP) inspections, and 
medical devices shall enter into force on the first day of the second 
month following the date on which the parties have exchanged letters 
confirming the completion of their respective procedures for the entry 
into force of that agreement.
     (b) That agreement including any sectoral annex may, through the 
Joint Committee, be amended in writing by the parties to that 
agreement. Those parties may add a sectoral annex upon the exchange of 
letters. Such annex shall enter into force 30 days following the date 
on which those parties have exchanged letters confirming the completion 
of their respective procedures for the entry into force of the sectoral 
annex.
     (c) Either party to that agreement may terminate that agreement in 
its entirety or any individual sectoral annex thereof by giving the 
other party to that agreement 6-months notice in writing. In the case 
of termination of one or more sectoral annexes, the parties to that 
agreement will seek to achieve by consensus to amend that agreement, 
with a view to preserving the remaining Sectoral Annexes, in accordance 
with the procedures in this section. Failing such consensus, that 
agreement shall terminate at the end of 6 months from the date of 
notice.
     (d) Following termination of that agreement in its entirety or any 
individual sectoral annex thereof, a party to that agreement shall 
continue to accept the results of conformity assessment procedures 
performed by conformity assessment bodies under that agreement prior to 
termination, unless a regulatory authority in the party decides 
otherwise based on health, safety and environmental considerations or 
failure to satisfy other requirements within the scope of the 
applicable sectoral annex.


Sec. 26.81   Final provisions.

    (a) The sectoral annexes referred to in Sec. 26.80(a), as well as 
any new sectoral annexes added pursuant to Sec. 26.80(b), shall form an 
integral part of the ``Agreement on Mutual Recognition Between the 
United States of America and the European Community,'' from which this 
part is derived.
    (b) For a given product or sector, the provisions contained in 
subparts A and B of this part shall apply in the first place, and the 
provisions of subpart C of this part in addition to those provisions. 
In the case of any inconsistency between the provisions of subpart A or 
B of this part and subpart C of this part, subpart A or B shall 
prevail, to the extent of that inconsistency.
    (c) The agreement from which this part is derived shall not affect 
the rights and obligations of the parties under any other international 
agreement.
    (d) In the case of subpart B of this part, the parties shall review 
the status of such subpart at the end of 3 years from the date 
described in Sec. 26.80(a).

    Dated: July 23, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-29609 Filed 11-5-98; 8:45 am]
BILLING CODE 4160-01-F