[Federal Register Volume 66, Number 127 (Monday, July 2, 2001)]
[Notices]
[Pages 34945-34947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-0239]


Medical Devices; Guidance on Resolving Scientific Disputes 
Concerning the Regulation of Medical Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Resolving Scientific Disputes 
Concerning the Regulation of Medical Devices.'' The guidance describes 
the role and operation of the Medical Devices Dispute Resolution Panel 
of the Medical Devices Advisory Committee (the Dispute Resolution 
Panel), the types of controversies eligible for review by the Dispute 
Resolution Panel, and recommendations for submitting a request for 
review.

DATES:  Submit written comments at any time.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the guidance document entitled ``Resolving Scientific Disputes 
Concerning the Regulation of Medical Devices'' to the Division of Small 
Manufacturers Assistance (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send two self-addressed labels to assist that office in 
processing your request, or fax your request to 301-443-8818. Submit 
written comments concerning this guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Comments should be identified with the 
docket number found in brackets in the heading of this document. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Les S. Weinstein, Center for Devices 
and Radiological Health (HFZ-5), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-6220, ext. 119.

SUPPLEMENTARY INFORMATION:

I. Background

     Section 404 of the Food and Drug Administration Modernization Act 
(FDAMA) of 1997 (section 562 of the Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360bbb-1)) requires FDA to establish procedures for the 
review of scientific controversies where there is not already an 
existing right of review. Although FDA believes existing procedures, 
such as internal agency review of decisions under Sec. 10.75 (21 CFR 
10.75), provide for an appropriate review of most, if not all, 
disputes, the Center for Devices and Radiological Health (CDRH) is 
developing new procedures to ensure effective and timely review of 
scientific disputes. In fact, CDRH has recently taken significant steps 
to achieve this objective, including the appointment of its first CDRH 
Ombudsman and the establishment of an advisory Dispute Resolution 
Panel. CDRH is now announcing a final guidance document on the use of 
this new Dispute Resolution Panel to facilitate the fair and rapid 
resolution of scientific disputes.
    This guidance supersedes the April 27, 1999 (64 FR 22617), draft 
guidance document entitled ``Resolving Scientific Disputes Concerning 
the Regulation of Medical Devices: An Administrative Procedures Guide 
to Use of the Medical Devices Dispute Resolution Panel.''
    The Dispute Resolution Panel, chartered on August 18, 1999, has 
five standing members (including a nonvoting industry representative 
and a nonvoting consumer representative), and three additional 
temporary voting members appointed for each particular dispute. 
Standing members will have broad, crosscutting scientific, clinical, 
analytical, or mediation skills. Temporary members will be chosen based 
on their experience, expertise, or analytical skills relevant to the 
review of each particular dispute. FDA published a notice in the 
Federal Register of November 10, 1999 (64 FR 61352), requesting 
nominations for the Dispute Resolution Panel members. The five standing 
members have since been appointed, and the first meeting of the Dispute 
Resolution Panel, an open public session, was held on October 31, 2000; 
the Dispute Resolution Panel members heard presentations from FDA and 
the device industry on the role of this panel in dispute resolution.

A. Response to Comments on the Draft Guidance

    Three comments were submitted concerning the April 27, 1999, draft 
guidance, two from medical device industry associations--Health 
Industry Manufacturers Association (now AdvaMed) and the Medical Device 
Manufacturers Association, and one from a device firm. CDRH's response 
to the significant comments follows:

[[Page 34946]]

Why a guidance document and not a regulation?

    Two comments stated that FDA should issue a regulation instead of a 
guidance document to establish procedures to resolve scientific 
disputes.
    FDA believes that it is not required to issue a regulation 
concerning the Dispute Resolution Panel procedures. The relevant 
section of FDAMA required a regulation only in those cases where no 
other statutory provision or a codified regulation provided a right of 
review of the matter in controversy. At the time of FDAMA's enactment, 
FDA already had a wide range of dispute resolution mechanisms in place, 
including Sec. 10.75, ``Internal agency review of decisions.'' That 
regulation permits any interested person to obtain review of any FDA 
decision. To implement the dispute resolution section of FDAMA, FDA 
amended Sec. 10.75 to make it clear that a scientific controversy may 
be brought before an advisory panel or committee in appropriate 
circumstances. The agency concluded that a new regulation was not 
required. However, each center prepared guidance setting forth 
procedures tailored to meet the needs of persons affected by the 
different processes used by each center. CDRH published a general 
guidance on dispute resolution within the center, ``Medical Device 
Appeals and Complaints'' (February, 1998), chartered and staffed the 
Dispute Resolution Panel in 2000, and is issuing this guidance to 
facilitate use of that Panel. Furthermore, FDA believes it is important 
to develop experience under the final guidance before considering 
whether it might be useful, even though not required, to issue a 
regulation at some point in the future. The guidance permits both CDRH 
and industry greater flexibility in resolving a particular controversy 
than a regulation would.

B. Independence of the Process

    One comment argued that the Dispute Resolution Panel should have 
final authority to reverse FDA decisions rather than just make 
recommendations to the CDRH Director. Another comment believed a 
Dispute Resolution Panel recommendation to the CDRH Director should 
stand unless the decision would be unlawful or pose a significant 
threat to public health.
    The legislative history indicates that the purpose of section 562 
of the act is ``to assure that the regulated industry receives a fair 
and impartial hearing and that the FDA receives sound recommendations 
and advice'' (H. Rept. 105-310 at 373 (October 7, 1997)) (emphasis 
added). Congress intends and expects any panel that reviews disputes 
will provide ``recommendations and advice,'' and that FDA must retain 
the final decisionmaking responsibility. The Dispute Resolution Panel 
will provide an important independent source of additional analysis and 
additional views that FDA will then use in making a final decision.
    Two comments focused on the independence of the process related to 
the role of CDRH officials in deciding whether a request for Dispute 
Resolution Panel review would be granted or denied.
    FDA is responding to these comments by strengthening the 
independence of the CDRH Ombudsman in that process. The Ombudsman will 
have authority to grant requests for Dispute Resolution Panel reviews, 
in consultation with the panel chair, without obtaining the approval of 
the Center Director, a Deputy Center Director, or anyone else in CDRH, 
although he would not be precluded from discussing the request with 
them to get background information about the dispute that would be 
helpful in making the decision to grant or deny review. However, if the 
Ombudsman wishes to deny a request for Dispute Resolution Panel review, 
the Ombudsman will consult with, and obtain the concurrence of, the 
appropriate Deputy Center Director.

C. Thresholds for Review of Scientific Disputes

    Two comments objected to statements in the draft guidance to the 
effect that a request for Dispute Resolution Panel review must 
primarily concern a scientific controversy regarding an FDA ``decision 
or action.'' The comments prefer an approach that would permit 
disagreements to be brought to the Dispute Resolution Panel ``early'' 
in the product review process, such as disagreements about the 
reasonableness of FDA data requirements, before there was an actual 
decision or action by the agency.
    FDA agrees that there may be some early disputes that would be 
appropriate for, and could benefit from, a review by the Dispute 
Resolution Panel and has revised the guidance to include such examples.

D. Timeliness of the Process

    Several comments were concerned that the process described in the 
draft guidance will not ensure timely review of disputes.
    FDA has revised the guidance to streamline the process and tighten 
some of the timeframes for processing and reviewing disputes. In most 
cases, CDRH expects matters accepted for Dispute Resolution Panel 
review to receive a final decision within 90 to 120 days of receipt of 
the request. Practical and administrative constraints preclude 
developing a timeframe shorter than this.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the Dispute Resolution Panel procedures for resolving scientific 
disputes. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach 
may be used if such approach satisfies the applicable statute and 
regulations.
    The agency has adopted good guidance practices (GGPs), which set 
forth the agency's regulations for the development, issuance, and use 
of guidance documents (21 CFR 10.115; 65 FR 56468, September 19, 2000.) 
This guidance document is issued as a level 1 guidance in accordance 
with the GGP regulations.
    As the agency gains experience with the Dispute Resolution Panel 
process, this guidance document may be revised from time to time.

III. Electronic Access

    In order to receive ``Resolving Scientific Disputes Concerning The 
Regulation Of Medical Devices'' via your fax machine, call the CDRH 
Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-
tone telephone. Press 1 to enter the system. At the second voice prompt 
press 1 to order a document. Enter the document number (1121) followed 
by the pound sign (#). Follow the remaining voice prompts to complete 
your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh.

[[Page 34947]]

IV. Paperwork Reduction Act of 1995

    The information collection provisions contained in this guidance 
have been approved by the Office of Management and Budget (OMB) under 
OMB control number 0910-0467.

V. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this guidance at any time. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments are to be identified with the docket 
number found in brackets in the heading of this document. The guidance 
document and received comments are available for public examination in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: June 15, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-16472 Filed 6-29-01; 8:45 am]
BILLING CODE 4160-01-S