[Federal Register: April 25, 2000 (Volume 65, Number 80)]
[Proposed Rules]               
[Page 24144-24158]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap00-27]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 821

[Docket No. 00N-1034]

 
Medical Devices; Device Tracking

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
the medical device tracking regulations. The scope of the regulation 
and certain patient confidentiality requirements must be amended to 
conform to changes made in section 519(e) of the Federal Food, Drug, 
and Cosmetic Act (the act) by the FDA Modernization Act of 1997 
(FDAMA). FDA also proposes nonsubstantive revisions to remove outdated 
references or simplify terminology.

DATES: Submit written comments by July 24, 2000. See section IV of this 
document for the proposed effective date of a final rule based on this 
document. Submit written comments on the information collection 
requirements by May 25, 2000.

ADDRESSES: Submit written comments on the proposed rule to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit written comments regarding 
the information collection requirements to the Office of Information 
and Regulatory Affairs Office of Management and Budget (OMB), New 
Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 
20503, Attn: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Chester T. Reynolds, Center for 
Devices and Radiological Health (HFZ-300), Food and Drug 
Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4618.

SUPPLEMENTARY INFORMATION:

I. Background

A. The SMDA and Device Tracking Regulations

    The Safe Medical Device Act of 1990 (the SMDA) (Public Law 101-629) 
became law on November 28, 1990. It added mandatory and discretionary 
device tracking provisions to the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 301 et seq.) under new section 519(e) (21 U.S.C. 
360i(e)).
    As added by the SMDA, new section 519(e)(1) mandated the adoption 
of a method of tracking by any person registered under section 510 of 
the act (21 U.S.C. 360) and engaged in the manufacture of a device if 
its failure would be reasonably likely to have serious adverse health 
consequences and the device was either a permanently implantable device 
or a life-sustaining or life-supporting device used outside a device 
user facility. New section 519(e)(2) authorized FDA, in its discretion, 
to ``designate'' other devices that must be tracked, to protect the 
public health and safety.
    On August 16, 1993, FDA published in the Federal Register (58 FR 
43442) the final rule setting forth regulations governing the tracking 
of medical devices, as provided by the SMDA under sections 519(e)(1) 
and (e)(2) of the act. Elsewhere in the same Federal Register (58 FR 
43451), FDA published a rule amending the illustrative list of those 
devices FDA considered subject to tracking under the mandatory criteria 
under section 519(e)(1) and the list of devices FDA designated as 
subject to tracking under section 519(e)(2). The final tracking 
regulations for medical devices, including the amended lists of tracked 
devices, went into effect on August 29, 1993, and are currently 
codified in part 821 of title 21 of the Code of Federal Regulations (21 
CFR part 821).

B. FDAMA Tracking Provisions

    FDAMA (Public Law 105-115) was enacted on November 21, 1997. 
Section 211 of FDAMA amended the tracking provision in section 
519(e)(1) of the act and became effective on February 19, 1998. Unlike 
the tracking provisions under the SMDA, which required tracking for any 
device meeting certain criteria, FDAMA allows FDA discretion in 
applying tracking requirements and provides that tracking requirements 
can be imposed only after issuance of an order.
    FDAMA authorizes FDA to issue orders that require a manufacturer to 
adopt a method of tracking a class II or class III device if its 
failure would be reasonably likely to have serious adverse health 
consequences, or it is intended to be implanted in the human body for 
more than 1 year, or it is a life-sustaining or life-supporting device 
used outside a device user facility. As amended by FDAMA, section 
519(e)(2) of the act provides that patients receiving a device subject 
to tracking may refuse to release, or refuse permission to release, 
their names, addresses, social security numbers, or other identifying 
information for tracking purposes.
    Section 519(e) of the act, as amended by FDAMA, provides that FDA 
`` may by order require a manufacturer to adopt a method of tracking.'' 
Such an order specifies to the manufacturer the class II or class III 
device(s) to be tracked. FDA interprets the discretion inherent in 
``may'' to allow the agency to consider additional relevant factors in 
determining whether to issue a tracking order for a device that meets 
the criteria in amended section 519(e)(1) of the act.
    The discretionary authority to issue tracking orders, and the three 
statutory criteria that operate independently of one another in section 
519(e)(1) of the act, allow the agency to accomplish the intended 
purpose of device tracking under FDAMA, as identified by Congress, 
i.e., to facilitate the recall of dangerous or defective devices, under 
section 518(e) of the act (S. Rept. 108, 105th Cong., 1st sess. 37 
(1997)).

II. Implementation of FDAMA Tracking Authority

A. Public Meeting/Manufacturer Notification

    On December 18, 1997, FDA published a Federal Register notice (62 
FR 66373) announcing the agency's intention to hold a public meeting on 
January 15, 1997, in Rockville, MD to discuss changes in medical device 
tracking and postmarket surveillance authorities under FDAMA. In 
particular, the agency was interested in discussing whether it should 
consider additional nonbinding factors to supplement the statutory 
criteria, under FDAMA, in determining whether tracking requirements 
should be ordered by FDA.
    On December 19, 1997, FDA sent letters to manufacturers having 
responsibilities to track devices under section 519(e) of the act. 
These letters advised that FDAMA would implement important statutory 
changes in medical device tracking, which had been authorized 
previously under the SMDA. The letters noted FDA's December 18, 1997, 
Federal Register notice announcing the public meeting it would conduct 
on January 15, 1998, to discuss

[[Page 24145]]

such changes. The letters also advised that existing device tracking 
requirements imposed by previously issued FDA regulations or FDA orders 
would remain in effect until FDA notified a firm of any changes in its 
responsibilities.
    At the January 15, 1998, public meeting, written and oral comments 
were received from consumer groups, clinicians, manufacturers, and 
device industry associations. These comments addressed factors FDA 
should consider in requiring tracking and ranged from FDA consideration 
of clinical management issues, and the use of alternative tracking 
mechanisms, to consideration of the likelihood of device failure.

B. Issuance of New Tracking Orders

    On February 11, 1998, FDA issued orders to manufacturers who would 
be required to track their devices under section 519(e) of the act, as 
revised by FDAMA. The orders were issued for 28 types of devices, which 
the agency determined met the revised tracking criteria under FDAMA. 
The orders became effective on February 19, 1998, the effective date of 
the revised tracking provision under FDAMA. The 28 devices subject to 
these new orders included the 26 device types previously identified as 
subject to tracking under the SMDA criteria in the agency's tracking 
regulation at Sec. 821.20(b)(1), (b)(2), and (c). Two device types not 
previously listed as subject to tracking in the regulation, namely, 
arterial stents and intraocular lenses, were also the subject of new 
tracking orders under FDAMA.
    In the Federal Register of March 4, 1998 (63 FR 10638), FDA 
published a notice identifying the 28 device types subject to the 
orders. The notice announced, again, FDA's intention to review and 
reconsider the imposition of tracking requirements for these devices, 
in light of its discretionary authority under FDAMA, to not require the 
tracking of devices that meet the statutory criteria. The notice also 
identified 13 devices that met the statutory criteria and that were 
subject to the February 1998 tracking orders, but that may be removed 
from the tracking requirement based on other factors. Comments were 
solicited on which nonbinding factors should be considered in making 
such discretionary tracking determinations.

C. Tracking Guidance Documents and FDA Reconsideration, Rescission, and 
Additional Issuance of Tracking Orders

    In the March 4, 1998, Federal Register, FDA also published a notice 
of availability of the guidance document entitled ``Guidance on Medical 
Device Tracking'' (63 FR 10640). This document provided guidance to 
manufacturers and distributors about their tracking responsibilities 
under section 519(e) of the act, as amended by FDAMA. It discussed what 
statutory and regulatory requirements had changed, and what 
requirements remained the same, and represented FDA's current thinking 
on medical device tracking under the FDAMA amendments.
    Beginning on August 26, 1998, FDA issued orders to manufacturers, 
rescinding the tracking orders it issued, effective February 19, 1998, 
for 14 types of devices manufactured by firms, including intraocular 
lenses and arterial stents. The agency determined, in its discretion, 
that these 14 device types did not warrant continued tracking based on 
the nonbinding factors, even though the statutory criteria were met. 
These nonbinding factors included: (a) The likelihood of sudden, 
catastrophic failure, (b) the likelihood of significant adverse 
clinical outcomes, and (c) the need for prompt professional 
intervention.
    On December 14, 1998, FDA issued orders to manufacturers of dura 
mater devices, requiring them to track the devices under section 519(e) 
of the act, as amended by FDAMA. These medical devices met the 
statutory criteria and may have significant adverse clinical outcomes.
    In the February 12, 1999, Federal Register, FDA published a notice 
of availability of the revised final guidance document entitled 
``Guidance on Medical Device Tracking'' (64 FR 7197). It replaced the 
previous final guidance issued on March 4, 1998. The revised final 
guidance of February 12, 1999, stated the agency's current thinking on 
manufacturer and distributor tracking responsibilities, and explained 
statutory and regulatory requirements that either changed or remained 
unchanged under medical device tracking revisions made under FDAMA.
    The guidance announced on February 12, 1999, provided an updated 
list of devices that were subject to tracking orders. It also provided 
the factors, such as the likelihood of sudden, catastrophic failure or 
significant, adverse clinical outcomes, or the need for prompt 
professional intervention, that FDA may use, in addition to the 
statutory criteria, in deciding whether to require the tracking of a 
device. It mentioned, as well, FDA's December 1998 issuance of tracking 
orders for dura mater devices.
    On September 28, 1999, FDA issued orders to manufacturers of stent 
grafts intended to treat abdominal aortic aneurysms, requiring them to 
track the devices. Upon reviewing premarket applications, the agency 
determined these devices meet the statutory tracking criteria of 
amended section 519(e), because their failure would be reasonably 
likely to have serious adverse health effects. On January 24, 2000, FDA 
issued a revised ``Guidance on Medical Device Tracking'' that 
identifies abdominal aortic aneurysm stent grafts as tracked devices.
    Agency experience indicates that industry and other interested 
parties were uncertain whether ``replacement heart valves'' subject to 
tracking include more than one type of heart valve. The January 24, 
2000, revised guidance document clarified that the category of 
replacement heart valves that must be tracked is limited to mechanical 
heart valves only and does not include human allograft (tissue) heart 
valves.
    There was similar uncertainty concerning which infusion pumps must 
be tracked. The February 1999 guidance document identified ``infusion 
pumps, except those designated and labeled for use exclusively for 
fluids with low potential risks, such as enteral feeding or anti-
infectives,'' as types of pumps subject to tracking. This description 
caused difficulty because infusion pump labeling does not always make 
clear the types of fluids the pumps are intended to deliver. FDA 
reevaluated the tracking status of these devices and clarified, in its 
January 24, 2000, guidance that tracking is required only for 
electromechanical infusion pumps used outside device user facilities.

III. Proposed Changes in Tracking Regulation

    On February 19, 1998, FDAMA amended section 519(e) of the act. By 
operation of statute, certain provisions in the tracking regulation, 
part 821, became inconsistent with the tracking requirements as revised 
by FDAMA. This proposed rule revises certain parts of part 821 to 
conform with section 519 of the act, as amended. FDA is proposing to 
revise the scope of the tracking requirements, including the 
appropriate modification of certain definitions and certain 
requirements relating to patient confidentiality, to reflect FDAMA's 
changes.
    In addition to changes in the proposed regulation that would 
reflect the changes already implemented under FDAMA, FDA proposes to 
simplify the regulation in a few nonsubstantive areas. These include: 
Removing explicit references to effective dates of provisions that have 
been in effect since 1993 (Sec. 821.1(c)); removing references to

[[Page 24146]]

procedures for filing petitions before August 29, 1993 (Sec. 821.2(d)); 
and substituting the simple inclusive term, ``tracked devices,'' in 
referring to devices intended for single use or multiple use that are 
subject to tracking, in place of the specific terms, ``life-sustaining 
or life-supporting devices used outside device user facilities'' and 
``permanent implants'' (Sec. 821.25(a)(2) and (a)(3)).
    Other than the proposed changes described above, parts of the 
tracking regulation that were not affected by FDAMA remain unchanged. 
Except for the nonsubstantive terminology change noted above, there are 
no proposed revisions to: The regulation's system and content 
requirements of tracking; the obligations of persons other than device 
manufacturers, such as distributors; records and inspection 
requirements; and record retention requirements.
    Each of the revisions proposed for amending the medical devices 
tracking regulation is discussed in more detail below.
    1. FDA is proposing to amend Sec. 821.1 Scope, by revising 
paragraph (a) to conform its language to the statutory language in 
section 519(e) of the act, as amended by FDAMA.
    Previously, under the statutory tracking provisions of section 
519(e)(1) of the act, as added by the SMDA, the scope of the tracking 
regulations in paragraph (a) applied the requirement to adopt a method 
of tracking to any person who registered under section 510 of the act 
as the manufacturer of a device, if the device's failure would be 
reasonably likely to have a serious adverse health consequence and if 
it was either a permanently implantable device or a life-sustaining or 
life-supporting device used outside a device user facility. The 
previous SMDA tracking provision in section 519(e)(2) also allowed the 
agency to require, in its discretion, tracking for any other device 
which did not otherwise meet the statutory tracking criteria in section 
519(e)(1).
    FDAMA has changed the scope of the tracking provisions in several 
ways, as follows:
    a. The tracking provision in section 519(e) of the act does not 
require tracking even if the statutory criteria are met unless FDA 
issues an order that directs a manufacturer to track a device. Under 
the SMDA, devices that met the certain statutory criteria were subject 
to tracking automatically, even if FDA did not issue an order.
    b. FDAMA allows FDA to exercise discretion in determining whether a 
device which meets the criteria in section 519(e) shall be tracked. 
SMDA did not allow FDA the discretion to excuse devices from tracking 
requirements if the devices met the statutory criteria.
    c. Under FDAMA, the types of persons subject to tracking are no 
longer linked to registration requirements under section 510 of the 
act. As amended, the tracking provision requires manufacturers who are 
issued a FDA tracking order to track the device(s).
    d. FDAMA also modifies the criteria by which devices may be subject 
to tracking. Formerly, under the SMDA's section 519(e)(1), tracked 
devices were those that ``the failure of which would be reasonably 
likely to have serious adverse health consequences and which is (A) a 
permanently implantable device, or (B) a sustaining or life supporting 
device used outside a device user facility * * *.''
    Under revised section 519(e)(1) of FDAMA, FDA may order a 
manufacturer to track only a ``class II or class III device (A) the 
failure of which would be reasonably likely to have serious adverse 
health consequences; or (B) which is (i) intended to be implanted in 
the human body for more than 1 year, or (ii) a life sustaining or life 
supporting device used outside a device user facility.''
    In addition, the agency may no longer designate a device as one 
that requires tracking to protect the public health, if the device does 
not meet any of the criteria for tracked devices in section 519(e) of 
the act. Former section 519(e)(2) under the SMDA allowed FDA discretion 
to order tracking for devices that did not meet statutory criteria.
    FDA is proposing to revise the language in paragraph (a) of 
Sec. 821.1 to conform to the amended statutory language in section 
519(e) of the act. Under proposed Sec. 821.1(a), the scope of the 
tracking regulation would reflect the revised statutory language in 
section 519(e)(1) to state tracking may only be required after certain 
statutory criteria are met.
    2. FDA is proposing to revise the third sentence in paragraph (b) 
in Sec. 821.1, which describes persons subject to tracking 
requirements, by removing the words, ``must register under section 510 
of the act,'' and substituting the words, ``are subject to tracking 
orders.'' As noted above, this change reflects the revisions made to 
section 519(e) by FDAMA. The revised tracking requirements, as amended 
by FDAMA, are triggered for the manufacturer by the issuance of a FDA 
tracking order, not by registration requirements.
    3. FDA is proposing to remove paragraph (c) from Sec. 821.1 and to 
redesignate paragraphs (d) and (e) as paragraphs (c) and (d), 
respectively. Current Sec. 821.1(c) was included in the final tracking 
regulations to clarify that the effective date for the tracking 
requirements under the SMDA was August 29, 1993. Because the 
requirements of these regulations have been in effect since August 29, 
1993 and have been implemented by industry for more than 5 years, it is 
not necessary to include the effective date in the current regulation.
    4. FDA proposes amending Sec. 821.2 Exemptions and variances, by 
removing paragraph (d). Paragraph (d) refers to the procedures that FDA 
used to handle tracking petitions received prior to the August 29, 
1993, effective date of the tracking regulation. Because all of those 
petitions have been responded to, there is no longer any need to 
include procedures relating to such petitions.
    5. FDA is proposing to amend Sec. 821.3 Definitions, by revising 
the definition of ``Importer'' in paragraph (b). ``Importer'' under the 
current regulation is defined as ``the initial distributor of an 
imported device who is required to register under section 510 of the 
act and Sec. 807.20 of this chapter. `Importer' does not include anyone 
who only performs a service for the person who furthers the marketing, 
i.e., brokers, jobbers, or warehouser.''
    FDA is proposing to remove the current language, ``required to 
register under section 510 of the act and Sec. 807.20 of this 
chapter,'' from the end of the first sentence in the definition and to 
replace it with the phrase, ``subject to a tracking order.'' FDA 
proposes that ``Importer'' be defined as ``the initial distributor of 
an imported device who is subject to a tracking order.'' The remainder 
of the definition would be unchanged.
    As explained previously, FDAMA removed the requirement that persons 
subject to registration requirements were automatically required to 
track their devices if the devices met certain criteria. The revised 
definition of ``importer'' reflects that tracking requirements are no 
longer triggered by registration requirements and that FDA must issue 
an order to such persons before they can be subject to tracking 
requirements.
    6. FDA is proposing to amend Sec. 821.3 Definitions, by revising 
the definition of ``Permanently implantable device'' in paragraph (f). 
A `` permanently implantable device'' is currently defined as:
    * * * a device that is intended to be placed into a surgically or 
naturally formed cavity of the human body to

[[Page 24147]]

continuously assist, restore, or replace the function of an organ 
system or structure of the human body throughout the useful life of the 
device. The term does not include any device which is intended and used 
only for temporary purposes or which is intended for explantation.
    Under the statutory tracking criteria added by the SMDA, section 
519(e)(1)(A) required the mandatory tracking of a ``permanently 
implantable device,'' if its failure was reasonably likely to have 
serious adverse health consequences. To implement this provision in the 
absence of further statutory clarification, FDA defined the meaning of 
``permanently implantable device'' in Sec. 821.3(f) to require such 
implants to ``continuously assist, restore, or replace the function of 
an organ system or structure of the human body'' throughout their 
useful life. Implanted devices intended for temporary use or 
explantation were not included in the meaning of the term.
    The type of implanted device that may be subject to tracking under 
section 519(e), as amended by FDAMA, has changed and must exceed a 
minimum implantation time period. Under the statutory tracking criteria 
of FDAMA, amended section 519(e)(1)(B)(i) now provides that FDA may 
order the tracking of a class II or class III implanted device, only if 
the device ``is intended to be implanted in the human body for more 
than 1 year.''
    FDA is proposing to revise the definition in Sec. 821.3(f) as 
follows:
    Device intended to be implanted in the human body for more than 1 
year means a device that is intended to be placed into a surgically or 
naturally formed cavity of the human body for more than 1 year to 
continuously assist, restore, or replace the function of an organ 
system or structure of the human body throughout the useful life of the 
device. The term does not include any device which is intended and used 
only for temporary purposes or which is intended for explantation in 1 
year or less.
    FDA is proposing to change the type of implanted device defined 
under Sec. 821.3(f) from ``permanently implantable device'' to ``device 
intended to be implanted in the human body for more than 1 year.'' This 
revision reflects the minimum implantation time period specified by 
FDAMA for the type of implanted device which FDA may order to be 
tracked under the revised statutory criteria of section 519(e). The 
agency is also proposing to add the phrase, ``for more than 1 year,'' 
in the first sentence of the revised definition after the phrase, ``of 
the human body.'' At the end of the second sentence, FDA is proposing 
to add the phrase, ``in 1 year or less.'' These latter two revisions 
further incorporate into the revised definition the minimum 
implantation time period effected by the FDAMA amendment.
    FDA believes that devices implanted for more than 1 year must 
continue to perform the function for which they were designed and 
implanted, throughout their useful life. FDA continues to believe that 
implanted devices which may remain ``permanently'' in the body, but 
whose function may be replaced by natural or other processes after a 
given period of time, should not be tracked (57 FR 22973, May 29, 
1992). Thus, FDA is proposing to retain the ``continuously assist, 
restore, or replace'' portion of the current definition as a condition 
of meeting the criterion in section 519(e)(1)(B)(i) of the act.
    7. FDA is proposing to amend Sec. 821.20 Devices subject to 
tracking, by revising paragraph (a) to conform to the tracking 
provision of section 519(e) of the act, as amended by FDAMA. Current 
paragraph (a) conforms to the tracking provision that was added to the 
act under section 519(e) by the SMDA. It required the tracking of 
devices that met the statutory tracking criteria for devices in section 
519(e) and also required the tracking of devices that FDA, in its 
discretion, designated as requiring tracking.
    Proposed paragraph (a) would conform to the statutory language of 
the revised section 519(e) under FDAMA. Accordingly, proposed 
Sec. 821.20(a) would require the manufacturer of a class II or class 
III device to track the device when ordered by FDA to do so, under the 
agency's discretion, after making a determination that such a device is 
one the failure of which would be reasonably likely to have serious 
adverse health consequences, or is one which is intended to be 
implanted in the human body for more than a year, or is one which is 
life-sustaining or life-supporting and used outside a device user 
facility, and is one which warrants tracking.
    8. FDA proposes the further revision of Sec. 821.20 Devices subject 
to tracking, by the removal of paragraph (b), paragraph (b)(1) and the 
table in (b)(1), paragraph (b)(2) and the table in paragraph (b)(2), 
and paragraph (c) and the table in paragraph (c).
    Under the SMDA tracking provision in previous section 519(e) of the 
act, the manufacturer of a device was required by statute to track the 
device if the device met the criteria set forth in section 519(e)(1). 
FDA was not required to issue an order for a device included in this 
section. It was the manufacturer's responsibility to track devices that 
met the statutory criteria. Under prior section 519(e)(2), the 
manufacturer was also required to track any device designated by FDA to 
require tracking. This section required FDA to issue an order.
    Current paragraph (b) of Sec. 821.20 sets out the responsibility of 
manufacturers to identify whether their devices met the criteria for 
tracking under section 519(e)(1), as added by the SMDA, and to initiate 
tracking. To assist manufacturers, paragraph (b) provided guidance 
concerning the types of devices FDA regarded as subject to tracking 
under the criteria in the regulation and previous section 519(e)(1). 
This guidance was provided in the form of an illustrative listing of 
example devices. Example devices were listed for permanently 
implantable devices in the table under paragraph (b)(1). Example 
devices were listed for life-sustaining or life-supporting devices used 
outside device user facilities in the table under paragraph (b)(2).
    Current paragraph (c) of Sec. 821.20 sets out FDA's authority to 
designate devices for tracking, under section 519(e)(2) of the act, as 
added by the SMDA. The devices that FDA had designated, by order, under 
the SMDA, as subject to tracking were identified in the table under 
paragraph (c).
    FDA is proposing to remove current Sec. 821.20(b), (b)(1) and its 
table, (b)(2) and its table, and (c) and its table because they no 
longer reflect the criteria for tracking, or a correct list of devices 
subject to tracking under section 519(e), as revised by FDAMA. Under 
the current tracking provisions of section 519(e) (1), as amended by 
FDAMA, FDA is given the authority to determine whether a class II or 
class III device meets the criteria, in sections 519(e)(1)(A) or (B), 
for devices that may require tracking. This determination is no longer 
the responsibility of the manufacturer, as current Sec. 821.20(b) 
indicates.
    FDA is authorized, under the current tracking provision under 
FDAMA, to exercise its discretion in determining whether a class II or 
class III device, meeting the criteria for ``trackable'' devices, 
warrants tracking. FDA must then issue a tracking order to the 
manufacturer of the class II or class III device when the agency 
determines that the device warrants being subject to the tracking 
requirement. Because each manufacturer of a device requiring tracking 
must receive a FDA tracking order, there is no need for FDA to

[[Page 24148]]

provide illustrative lists of example devices, as was done in current 
Sec. 821.20(b)(1) and (b)(2). Moreover, because Sec. 821.20(c) and the 
table under (c) listed devices subject to tracking orders under section 
519(e)(2) under SMDA criteria, that list is no longer relevant under 
the tracking criteria, as amended by FDAMA.
    As explained above, the current tracking requirement under section 
519(e) of the act, as amended by FDAMA, is triggered solely by the 
issuance of FDA tracking orders. No useful regulatory purpose would be 
served by replacing, in the tracking regulation at Sec. 821.20, 
previous illustrative lists of example devices requiring tracking under 
the SMDA, with lists of device types ordered by FDA to be tracked under 
FDAMA. Current manufacturers with tracking obligations have been 
notified by order and, therefore, do not need to look in the 
regulations to determine if FDA believes their devices meet the 
tracking criteria.
    Although distributors, final distributors, and multiple 
distributors of tracked devices will not be provided tracking orders, 
as manufacturers are, FDA believes it is more expeditious and effective 
to keep such interested parties apprised of revisions to device types 
subject to tracking orders, through the use of guidance or periodic 
Federal Register notices than it is to undergo the process of changing 
a list in a regulation. Tracking guidance or notices will be made 
available to interested parties through the agency's Internet and 
Facts-on-Demand websites. Their availability also will be announced 
through the publication of Federal Register notices. These procedures 
will be followed when appropriate because of changes in the types of 
tracked devices or changes in the agency's current thinking. The status 
and identification of tracked devices has already been disseminated 
successfully in this fashion through Federal Register notices published 
on March 4, 1998 (63 FR 10638 and 63 FR 10640) and February 12, 1999 
(64 FR 7197), and through tracking guidance documents made available 
through the Internet on these same dates.
    9. Because of the proposed removal of current Sec. 821.20(b), 
(b)(1), (b)(2) and (c), FDA is proposing to redesignate current 
Sec. 821.20(d) as Sec. 821.20(b). In proposed Sec. 821.20(b), FDA has 
edited, revised, and deleted certain provisions of current 
Sec. 821.20(d).
    Current Sec. 821.20(d) states: ``FDA, when responding to premarket 
notification (510(k)) submissions and approving premarket approval 
applications (PMA's), will notify the sponsor that FDA believes the 
device meets the criteria of section 519(e)(1) and therefore should be 
tracked.'' Proposed Sec. 821.20(b) states: ``When responding to 
premarket notification submissions and approving premarket approval 
applications, FDA will notify the sponsor by issuing a tracking order 
that FDA believes the device meets the criteria of section 519(e)(1) of 
the act and, by virtue of the order, is required to be tracked.''
    In revising current Sec. 821.20(d) (proposed redesignated 
Sec. 821.20(b)), FDA proposes to modify the language describing the 
content of 510(k) and PMA orders to accurately reflect that tracking 
requirements are accomplished by order under FDAMA.
    10. FDA is proposing to amend Sec. 821.25 Device tracking system 
and content requirements: manufacturer requirements, by revising the 
terms used in the introductory text of paragraphs (a)(2) and (a)(3) to 
identify the types of devices subject to requirements set out under 
Sec. 821.25(a)(2)(i) through (a)(2)(vii) and 821.25(a)(3)(i) through 
(a)(3)(viii), respectively.
    The current tracking regulation sets out different types of 
reporting requirements based on whether the device was: (1) Intended 
for single use or a permanent implant (Sec. 821.25(a)(2)) or (2) 
intended for multiple use (Sec. 821.25(a)(3)). In describing the types 
of tracked devices that were subject to the requirements in these 
paragraphs, the current regulation restates the statutory criteria of 
section 519(e) of the act, as added by the SMDA, that were used to 
subject devices to tracking. Accordingly, current Sec. 821.25(a)(2) 
tracks the SMDA language by describing those types of devices that were 
subject to requirements for single patient use and implant devices as 
``life-sustaining or life-supporting devices used outside a device user 
facility * * * and permanent implants * * *.'' Similarly, current 
Sec. 821.25(a)(3) tracks the SMDA language by describing those types of 
devices that were subject to requirements for multiple patient use 
devices as ``life-sustaining or life supporting devices used outside 
device user facilities * * * .''
    Proposed Sec. 821.25(a)(2) and (a)(3) would not change the 
reporting requirements for single patient use, implants, or multiple 
patient use devices. Proposed Sec. 821.25(a)(2) and (a)(3) merely would 
delete the descriptions of single use, implants, and multiple use 
devices that reflect SMDA criteria that no longer apply. Instead, 
proposed Sec. 821.25(a)(2) and (a)(3) substitute a description of 
devices that are subject to reporting requirements that is consistent 
with the section 519(e) of the act criteria that were amended by FDAMA. 
For simplification purposes, however, FDA is choosing not to fully 
restate the revised FDAMA section 519(e) of the act criteria for 
tracked devices. Proposed Sec. 821.25(a)(2) and (a)(3), instead, refer 
to devices subject to tracking as ``tracked devices.''
    Accordingly, in the introductory paragraph of Sec. 821.25(a)(2), 
FDA is proposing to remove the phrase, ``for life-sustaining or life-
supporting devices used outside a device user facility,'' and the 
statement, ``and permanent implants that are tracked devices.'' In 
their place, FDA is proposing to substitute the phrase, ``for tracked 
devices.'' Similarly, in the introductory paragraph of 
Sec. 821.25(a)(3), FDA is proposing to remove the phrase, ``for life-
sustaining or life-supporting devices used outside device user 
facilities,'' and the clause, ``and that are tracked devices.'' In 
their place, FDA is proposing to substitute the phrase, ``for tracked 
devices.''
    11. FDA proposes to further amend Sec. 821.25 Device tracking 
system and content requirements: manufacturer requirements, by revising 
paragraphs (a)(2)(iii) and (a)(3)(iv). These sections currently state 
that manufacturers must provide ``(t)he name, address, telephone 
number, and social security number (if available) of the patient'' 
receiving or using the device. FDA is proposing to revise these 
sections by adding, at the end of each of these paragraphs, the clause, 
``unless not released by the patient under Sec. 821.55(a);''.
    These proposed changes bring Sec. 821.25(a)(2)(iii) and (a)(3)(iv) 
into conformance with section 519(e)(2) of the act which, as amended by 
FDAMA, specifically states that patients receiving a tracked device may 
refuse to release, or refuse permission to release, the type of patient 
identifying information required under the current regulatory 
requirements.
    12. FDA proposes amending Sec. 821.30 Tracking obligations of 
persons other than device manufacturers: distributor requirements by 
revising paragraphs (b)(3) and (c)(1)(ii) in identical fashion. The 
semicolons at the end of both regulatory requirements would be changed 
to commas and the phrase, ``unless not released by the patient under 
Sec. 821.55(a);'' would be added following the comma in each 
requirement. These revisions are proposed for the reasons discussed 
above under item 11.
    13. FDA is proposing to amend Sec. 821.55 Confidentiality, by 
redesignating current paragraphs (a) and (b) as paragraphs (b) and (c),

[[Page 24149]]

respectively, and by adding new paragraph (a). Proposed Sec. 821.55(a) 
provides that any patient receiving a tracked device, subject to the 
requirements of this regulation, may refuse to release, or refuse 
permission to release, the patient's name, address, telephone number, 
and social security number, or other identifying information for 
tracking purposes. This change would incorporate the provision of 
section 519(e)(2) of the act, as amended by FDAMA, and discussed in 
section III paragraph 11 of this document previously, into the tracking 
regulation.
    Because the agency recognized that the accuracy of information in 
the tracking system was dependent, to some degree, on the cooperation 
of persons, such as patients, who were beyond the manufacturer's 
control, it has stated (57 FR 10702 at 10710, March 27, 1992) that 
persons required to track devices would only have to demonstrate a 
``good faith'' effort to collect required tracking information and 
document why certain information was not obtained. This same position 
applies to information not obtainable under section 519(e)(2) of the 
act and proposed Sec. 821.55(a).

IV. Effective Date

    FDA proposes that any final rule that may issue based on this 
proposal become effective 30 days after the date of publication of the 
final rule in the Federal Register.

V. Environmental Impact

    The agency has determined under 21 CFR 25.30 (h) that this proposed 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-721)), and the Unfunded Mandates Reform Act 
(Public Law 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 
the benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Unfunded Mandates Reform Act (in section 202) requires 
that agencies prepare an assessment of anticipated costs and benefits 
before proposing any expenditure by State, local, and tribal 
Governments, in the aggregate, or by the private sector of $100 million 
in any 1 year. Under the Regulatory Flexibility Act, unless an agency 
certifies that a rule will not have a significant impact on a 
substantial number of small entities, the agency must analyze 
regulatory options that would minimize any significant economic impact 
of a rule on small entities.
    Regulations implementing the tracking requirements of the Safe 
Medical Devices Act became effective on August 29, 1993. The purpose of 
device tracking is to ensure that manufacturers of certain devices 
establish tracking systems that will enable them to promptly locate 
devices in commercial distribution. Device tracking systems can reduce 
serious risks by facilitating patient notifications and device recalls. 
Manufacturers of certain devices are required to develop, document, and 
operate a tracking system that will allow them a quick notification to 
all distributors, health professionals, or patients of a recall or the 
existence of a serious health risk. The Food and Drug Administration 
Modernization Act of 1997 (FDAMA) amends the scope of devices that may 
be subject to tracking requirements, and requires the agency to issue 
an ``order'' notifying manufacturers to adopt a tracking method. This 
proposed rule codifies the FDAMA changes by amending the 1993 
regulation to give FDA greater flexibility to issue and rescind 
tracking orders in response to changing market risks. In December of 
1997, FDA advised manufacturers that the tracking requirements imposed 
by previous FDA regulations would remain in effect until the agency 
notified a firm of any change in responsibilities. On February 11, 
1998, FDA sent current tracking orders to manufacturers of all of the 
device types listed in the 1993 device tracking regulation. Beginning 
in August 1998, FDA used its discretionary authority under FDAMA to 
rescind tracking orders for approximately half of these devices because 
it was determined that they did not have a level of risk warranting 
device tracking. Later, FDA issued tracking orders to manufacturers of 
two additional devices known to be associated with serious risks and 
limited the scope for two other device types. The discussion below 
estimates the cost consequences attributable to these changes in the 
list of devices required to be tracked.
    A recent agency analysis projects that the cost to industry of 
maintaining device tracking systems will rise from approximately $40 
million in 1999, to $71 million in 2006 (Ref. 1). As detailed in that 
analysis, this estimate accounts for the FDAMA-related changes that: 
(1) Add approximately $1.0 million in new annualized costs to track the 
additional devices for which orders were sent in December 1998, and 
September 1999, and (2) save industry approximately $19.2 million per 
year by eliminating tracking for a number of device types and limiting 
the scope of another device to those used outside device user 
facilities. Although FDAMA changed the scope of devices subject to 
tracking, no requirements have been added for devices that are already 
tracked. Therefore, the manufacturers and distributors of devices that 
are already being tracked will not incur additional costs as a result 
of this proposed rule. The FDAMA-related changes to the 1993 list of 
devices result in net savings to industry of approximately $18.2 
million per year (i.e., $19.2 million minus $1.0 million). In the 
future, the total cost of industry device tracking systems may increase 
as devices are added or decrease as devices are rescinded. FDA could 
not forecast the cost or cost savings of such future actions, however, 
it is likely that these would be incurred at the same rate as they have 
since the requirements became effective in 1993.
    This proposed rule would also reduce agency costs by bypassing 
expensive rulemaking procedures each time a device is added to or 
removed from the tracking list. This analysis does not quantify these 
costs, although a substantial savings is expected from this more 
flexible and efficient system.
    FDA has reviewed this proposed rule and has determined it is 
consistent with the regulatory philosophy and principles identified in 
the Executive Order and these two statutes. Because the costs of the 
proposed rule total less than $100 million in any one year, the 
proposed rule is not a ``significant regulatory action'' under the 
Executive Order and FDA is not required to perform a cost benefit 
analysis under the Unfunded Mandates Reform Act.
    Although these changes have, so far, resulted in a net savings to 
industry, the manufacturers and distributors of the two added devices, 
which are both implants, will incur additional costs. The four 
manufacturers of these devices will incur total average annualized 
costs of approximately $982,000. The agency is unsure how many 
distributors are affected, but estimates that distributors will incur 
average annualized costs of $66,000. High-technology or specialty items 
such as implants usually move directly from the manufacturer to the

[[Page 24150]]

hospital,\1\ and therefore, the agency considers the hospital to be the 
final and only distributor in the distribution chain for implantable 
devices. There are approximately 5,057 community hospitals in the 
United States.\2\ If only 10 percent of these hospitals implant the 
estimated 22,000 units sold per year of the added devices, the average 
cost per hospital would be $130 per year. Based on 1997 gross revenue 
estimates of $564.4 billion for the 5,057 community hospitals,\3\ this 
$130 per hospital cost would be significantly lower than 1 percent of 
the $111.6 million average gross revenue per hospital. Therefore, under 
the Regulatory Flexibility Act (5 U.S.C. 605(b)), the agency certifies 
that the proposed rule would not have a significant economic effect on 
a substantial number of small entities.
---------------------------------------------------------------------------

    \1\ ``From Producer to Patient: Valuing the Medical Products 
Distribution Chain,'' Ernst & Whinney, prepared for the Health 
Industry Distributors Association, p. III-9.
    \2\ ``Hospital Statistics,'' Health Forum, an American Hospital 
Association Co., 1999 edition, table 3, p. 8.
    \3\ ``Hospital Statistics,'' Health Forum, an American Hospital 
Association Co., 1999 edition, table 3, p. 9.
---------------------------------------------------------------------------

VII. Submission of Comments

    Interested persons may, on or before July 24, 2000, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. 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. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

VIII. Paperwork Reduction Act of 1995

A. Summary

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3502). A 
description of these provisions is given below with an estimate of the 
annual reporting and recordkeeping burden. Included in the estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Medical Devices; Device Tracking (Amended)
    Description: FDA is proposing to amend the device tracking 
regulation to conform the regulation to, and implement, changes made in 
section 519(e)(1) and (e)(2) of the act by FDAMA.
    This proposed rule revises the scope, removes the lists of tracked 
devices, and amends certain confidentiality requirements of the current 
medical device tracking regulation (part 821). This proposed rule also 
proposes to make certain nonsubstantive revisions in the tracking 
regulation to remove outdated references or to simplify terminology.
    Under the proposed revised scope of the amended tracking 
regulation, FDA is requiring manufacturers of class II or class III 
devices, including repackers, relabelers, and importers of such 
devices, when required by tracking orders issued by FDA for particular 
devices, to adopt a method of tracking the devices throughout 
distribution to the device user or patient. Under proposed additional 
patient confidentiality provisions, patients may refuse, or refuse 
permission, to release particular identification information. Though 
revisions of certain other requirements are proposed for simplification 
purposes, tracking requirements are not changed substantively.
    Manufacturers of tracked devices, i.e., devices subject to FDA 
tracking orders, would continue to be required by the proposed amended 
regulation to gather, record, maintain, and make available during FDA 
inspection, and to provide within 3 or 10 working days, upon FDA 
request, information on the location and current users of tracked 
devices, and other use-related information. Upon receiving tracked 
devices, distributors, final distributors, and multiple distributors 
must continue to provide tracked device manufacturers with device 
identity and receipt information and, when applicable, patient identity 
and other related usage information.
    The purpose of these tracking requirements, as proposed for 
revision, continues to be to facilitate manufacturers identifying the 
current location and identity of all persons using tracked devices, to 
the extent permitted by patients. With this information, manufacturers 
of tracked devices and FDA can expedite the recall of distributed 
tracked devices that are dangerous or defective.
    Description of Respondents: Manufacturers, including repackers, 
relabelers, and importers, and distributors, final distributors, and 
multiple distributors involved in the manufacture and distribution of 
tracked devices. FDA estimates the burden of this collection of 
information as follows:

                             Table 1.--Estimated Average Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                           Annual frequency      Total annual        Hours per
   21 CFR section     No. of respondents     of  response          responses         response       Total hours
----------------------------------------------------------------------------------------------------------------
821.2 (also          4                    1                   4                        12              48
 821.30(e))
821.25(a)            1                    1                   1                        76              76
821.25(d)            19                   1                   19                        2              38
821.30(a), (b)       17,000               65                  1,113,295                 0.1666    185,475
821.30(c)(2)         1                    1                   1                        28              28
821.30(d)            17,000               13                  213,067                   0.1666     35,497
                                                                                                 ---------------
    Total                                                                                         221,162
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 24151]]


                                                     Table 2.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Annual Frequency      Total Annual
                   21 CFR Section                     No. of Respondents     per Response          Responses      Hours per Response      Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
821.25(b)                                                   207              41,731           8,638,334                   0.2899      2,504,253
821.25(c)                                                   207                   1                 207                  20.5          4,236\2\
821.25(c)(3)                                                207               1,017             210,562                   0.2899         61,042
                                                                                                                                     -------------------
    Total                                                                                                                             2,569,531
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Includes one-time burden of 1,584 hours.

B. Background Facts and Assumptions

    1. Average Figures
    Burden estimates for information collections are based on data and 
methods set forth in FDA's 1999 analysis, ``Cost Assessment of Medical 
Device Tracking,'' (Ref. 1). That analysis estimates industry costs for 
current device tracking systems through the year 2006 and cost savings 
for devices no longer tracked under FDAMA. Burdens shown in the tables 
1 and 2 of this document and described elsewhere in this document, are 
average annual figures for the years 1999 to 2001.
    2. Respondents
    FDA has issued tracking orders to 207 manufacturers to track 13 
types of devices intended to be implanted for more than 1 year 
(hereinafter referred to as ``tracked implants'') and 4 types of life-
sustaining or life-supporting devices that are used outside device user 
facilities (hereinafter referred to as ``tracked l/s-l/s devices''). 
FDA estimates that some 17,000 distributors, final distributors, and 
multiple distributors are subject to tracking reporting requirements as 
follows: 171 wholesalers, electromedical equipment; 1,252 retailers, 
hospital equipment and supplies; 10,500 home care dealers/medical 
equipment rental companies (median of 6,000 to 15,000 dealer estimate); 
and 5,057 U.S.-community hospitals (16,980 (total) rounded to 17,000).
    3. Tracked Implant Devices
    Using implantation procedures data from the National Center for 
Health Statistics for 1993 through 1996, FDA applies a 2 percent annual 
growth rate to estimate number of procedures for tracked implant 
devices from 1997 through 2006 (Ref. 1). Table 3 of this document shows 
1993 to 1996 figures, and table 4 of this document shows projections 
through 2001. FDA issued tracking orders for dura mater implants in 
December 1998 and for abdominal aortic aneurism (AAA) stent grafts in 
September 1999. Data for these devices are first considered in the 
appropriate years.

                 Table 3.--Number of Implantation Procedures Per Tracked Implants (1993 to 1996)
----------------------------------------------------------------------------------------------------------------
                                                     Number of       Number of       Number of       Number of
         Device Type             ICD\1\ Number     Procedures in   Procedures in   Procedures in   Procedures in
                                                       1993            1994            1995            1996
----------------------------------------------------------------------------------------------------------------
Implantable pacemaker pulse          37.8         123,000         139,000         136,000         155,000
 generator
Cardiovascular permanent             37.70-37.76  108,000         131,000         128,000         132,000
 implantable pacemaker
 electrode
Replacement heart valve              35.2          58,000          54,000          61,000          69,000
Automatic implantable                37.9          21,000          21,000          27,000          26,000
 cardioverter/defibrillator
Implanted cerebellar                  2.93          2,000           2,000           2,000           2,000
 stimulator
Implanted diaphragmatic/             34.85          2,000           2,000           2,000           2,000
 phrenic nerve stimulator
Implantable infusion pumps           86.06          7,000           7,000           6,000           9,000
Temporomandibular joint\2\           76.92          2,000           2,000           2,000           6,000
Ventricular bypass (assist)          37.61-37.63   33,000          35,000          48,000          56,000
 device
Dura mater                            2.12          6,000           6,000           8,000           6,000
Abdominal aortic aneurysm           n/a               n/a             n/a             n/a            n/a
 grafts
----------------------------------------------------------------------------------------------------------------
\1\Implantable cardiodefibrillator.
\2\This product category includes: Temporomandibular joint prosthesis, glenoid fossa prosthesis, and mandibular
  condyle prosthesis.

    Numbers of implantations correspond to numbers of distributed 
tracked implants. FDA assumes that tracked implants are distributed 
directly from manufacturers to final distributors, which are mostly 
hospitals.

[[Page 24152]]



 Table 4.--Tracked Implants: Estimates of Annual Distribution and Total
  Tracked Devices (1994 to 2001) (Based on Implantation Procedure Data)
------------------------------------------------------------------------
End of
 Year      New Implants\1\      Previous Implants       Total Tracked
------------------------------------------------------------------------
1994        393,000                     0               393,000
1995        412,000               393,000               805,000
1996        457,000               805,000             1,262,000
1997        466,140             1,262,000             1,728,140
1998        475,463             1,728,140             2,203,603
1999\2      491,339             2,203,603             2,694,942
 \
2000\3      516,166             2,694,942             3,211,108
 \
2001        526,489             3,211,108            3,737,598
------------------------------------------------------------------------
\1\Represents estimated number of tracked implants distributed annually.

\2\Estimated distribution for dura mater implants is included in 1999 to
  2001, et al., estimates.
\3\Estimated distribution for abdominal aortic aneurysm stent grafts is
  included in 2000 and 2001, et al., estimates.

    4. Tracked l/s-l/s Devices
    FDA uses unit shipment data and forecasts from 1992 and 1994 
published sources, in combination with various growth rates (Ref. 1) to 
estimate annual sales/distribution of four types of tracked l/s-l/s 
devices. See table 5 of this document.

                                   Table 5.--Tracked Life-Supporting Devices-Estimated Number of Units (1991 to 2001)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                            Breathing    Continuous       Direct Current Defibrillators and      Infusion Pumps (electromechanical only)
                                            Frequency    Ventilators                   Paddles                 -----------------------------------------
                  Year                      Monitors   --------------------------------------------------------
                                         --------------                 Alternate     Physician                    Syringe     Ambulatory    Total Units
                                           Total Units   Total Units   Care Units   Office Units   Total Units      Units         Units
--------------------------------------------------------------------------------------------------------------------------------------------------------
  1991                                        n/a           n/a        14,000         3,150        17,150           n/a           n/a           n/a
  1992                                        n/a           n/a        17,850         3,591        21,441           n/a           n/a           n/a
  1993                                        n/a           n/a        22,759         4,094        26,852           n/a           n/a           n/a
  1994                                     12,200         4,300        29,017         4,667        33,684        23,600        30,900        54,500
  1995                                     12,300         4,700        36,997         5,320        42,317        26,200        34,500        60,700
  1996                                     12,800         5,100        47,171         6,065        53,236        29,100        37,500        66,600
  1997                                     13,300         5,600        60,144         6,914        67,058        32,300        40,800        73,100
  1998                                     13,900         6,200        76,683         7,882        84,565        35,700        44,100        79,800
  1999                                     14,500         6,900        97,771         8,986       106,757        39,300        47,300        86,600
  2000                                     15,100         7,700       124,658        10,244       134,902        43,000        50,400        93,400
  2001                                     15,569         8,387       158,939        11,678       170,617        47,105        54,571       101,676
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 24153]]

C. Burden Estimates

    1. Under Sec. 821.2, manufacturers, importers, or distributors, 
including final distributors, and multiple distributors, may request 
exemptions and variances from tracking requirements. These requests 
must meet the requirements for filing a citizen petition under 
Sec. 10.30 (21 CFR 10.30). FDA's burden estimates for citizen petitions 
are approved under OMB control number 0910-0183.
    The estimate for Sec. 821.2 assumes requesters would need about 12 
additional hours per petition to provide information not required under 
Sec. 10.30, such as suitable alternative tracking methods justifying a 
variance. FDA has received an average of four requests a year for 
exemptions and variances from manufacturers, distributors, final 
distributors, and trade associations in behalf of such firms. Burdens 
for distributors, final distributors, and multiple distributors to 
submit variance or exemption requests, under Sec. 821.30(e), are 
included in the estimate for Sec. 821.2.
    2. Section 821.25(a) requires manufacturers to adopt a tracking 
method that can provide, upon FDA request--within 3 working days, for 
all tracked devices, prior to distribution to patients, data about the 
distributors, within 10 working days, for tracked devices for single 
patient use, after distribution to patients, data about the devices, 
shipping, patients, use, and physicians, and within 10 working days, 
for tracked devices for multiple patient use, after distribution to 
multiple distributors, data about the devices, shipping, multiple 
distributors, use, patients, and physicians.
    FDA has never requested such deadline disclosures. Assuming one 
occurrence a year, FDA estimates it would take a firm some 20 hours to 
provide location data for all tracked devices within 3 days, and 56 
hours to identify all patients and/or multiple distributors possessing 
tracked devices.
    3. Under Sec. 821.25(d), manufacturers must notify FDA of 
distributor noncompliance with reporting requirements. FDA is unaware 
of receiving any such notices and assumes only repeated noncompliance 
would be reported. FDA believes it would receive no more than 19 
notices in any year. This assumes manufacturers annually audit about 5 
percent of the data reported by distributors against data base entries 
and that some 10 percent of audited records (approximately 19,000) 
might be inaccurate and require further followup. FDA believes only 0.1 
percent of further audited data might represent repetitive distributor 
noncompliance and that it would take about 2 hours per incident to 
report repeated distributor noncompliance to FDA.
    4. Under Sec. 821.30(a), distributors, final distributors, and 
multiple distributors must report receipt related data to 
manufacturers, upon acquiring tracked devices. Under Sec. 821.30(b), 
final distributors of tracked devices, intended to be used by a single 
patient over the useful life of the device, must report patient and 
usage related information, upon distributing the devices to patients. 
The agency estimates distributor reporting burdens for tracked implants 
and tracked l/s-l/s devices as follows:
    Distributor reporting for tracked implants: Tracked implants are 
tracked devices intended for single patient usage. FDA assumes 
hospitals, for the most part, are the direct recipients of tracked 
implants. As final distributors, they must report both the receipt and 
implantation of tracked implants, but FDA believes most, in practice, 
make only one report to manufacturers at implantation. FDA believes 
most hospitals rely on manufacturer distribution records identifying 
initial consignees of devices, as required by the Quality System 
regulation (21 CFR 820.160), in lieu of reporting the receipt of 
tracked devices back to the manufacturers. Thus, only one report is 
attributed to final distributors of tracked implants in FDA's estimate.
    FDA estimates it would take 10 minutes (0.1666 hours) for final 
distributors to report tracking data for each tracked implant 
distributed during the year (``new implants'' per table 4 of this 
document). For 1999 to 2001, the average number of ``new implants'' per 
year is estimated as 511,331 devices, per table 4 as follows: 491,339 
devices (for 1999) + 516,166 devices (for 2000) + 526,489 devices (for 
2001) <divide> 3. The average annual burden for distributor reporting 
for these devices would be: 511,331 (average number of ``new 
implants'') x 1 final distributor per device x 1 data report per final 
distributor x 0.1666 hours per report = 85,188 hours.
    Distributor reporting for tracked l/s-l/s devices: FDA estimates 
there are from one to three, or a median of two, distributors or 
multiple distributors in distribution chains for three types of tracked 
l/s-l/s devices, that is, tracked breathing frequency monitors (infant 
apnea monitors), continuous ventilators, and direct current (DC)-
defibrillators and pads. There are no final distributors for tracked l/
s-l/s devices because each device is intended for multiple patient 
usage. Each distributor or multiple distributor would make one data 
report per device received during the year. See table 6 of this 
document for annual distribution.
    For 1999 to 2001, the average number of ``total units'' (table 5 of 
this document) and ``new devices'' (table 6 of this document) of the 
above three types of tracked l/s-l/s devices distributed per year would 
be 160,144, as estimated per table 5 as follows: 14,500 + 6,900 + 
106,757 devices (for 1999) + 15,100 + 7,700 + 134,902 devices (for 
2000) + 15,569 + 8,387 + 170,617 devices (for 2001) <divide> 3. The 
average annual burden for distributor reporting for these three types 
of tracked l/s-l/s devices is estimated as: 160,144 (average number of 
``new devices'') x 2 distributors or multiple distributors per device x 
1 data report per distributor or multiple distributor x 0.1666 hours 
per report = 53,360 hours.
    FDA estimates there are from one to five, or a median of three, 
distributors or multiple distributors in distribution chains for one 
type of tracked l/s-l/s device, that is, electromechanical infusion 
pumps that are tracked. For 1999 to 2001, the average number of ``total 
units'' (table 5 of this document) and ``new devices'' (table 6 of this 
document) of tracked electromechanical infusion pumps distributed per 
year would be 93,892 devices, as estimated per table 6 of this document 
as follows: 86,600 devices (for 1999) + 93,400 devices (for 2000) + 
101,676 devices (for 2001) <divide> 3. The average annual burden for 
distributor reporting for this one type of tracked l/s-l/s device would 
be: 93,892 (average number of ``new devices'') x 3 distributors or 
multiple distributors x 1 data report x 0.1666 hours = 46,927 hours.

[[Page 24154]]



              Table 6.--Tracked Life-Sustaining or Life Supporting Devices--Estimated Distribution
----------------------------------------------------------------------------------------------------------------
                   Breathing Frequency Monitors,          Infusion Pumps
                    Continuous Ventilators, and  --------------------------------
                          Defibrillators
   End of Year   --------------------------------                 Average No. of      Percent       Audits per
                                  Average No. of    New Devices    Distributors/      Audited          Year
                    New Devices    Distributors/                   Data Reports
                                   Data Reports
----------------------------------------------------------------------------------------------------------------
1994               50,184               2          54,500               3              5%               2
1995               59,317               2          60,700               3              5%               2
1996               71,136               2          66,600               3              5%               2
1997               85,958               2          73,100               3              5%               1
1998              104,665               2          79,800               3              5%               1
1999              128,157               2          86,600               3              5%               1
2000              157,702               2          93,400               3              5%               1
2001              194,572               2         101,676               3              5%               1
----------------------------------------------------------------------------------------------------------------

    5. Section 821.30(c)(1) requires multiple distributors to keep 
written records, containing patient identity and other information, 
each time a tracked device is distributed to patients (or users). The 
required information is recorded and/or kept on a daily basis by device 
rental and leasing firms, and other multiple distributors, as a 
customary and usual business practice, for purposes of billing, 
inventory control, liability protection, and other fiscal accounting. 
Therefore, the burden hours attributed to this provision are not 
included in the burden estimate (5 CFR 1320.3(b)(2)).
    6. Under Sec. 821.30(c)(2), multiple distributors must provide data 
on current users of tracked devices, current device locations, and 
other information, within 5 working days of a request from a 
manufacturer, or within 10 working days of a request from FDA. FDA is 
unaware of any manufacturer making such a request, nor has the agency 
made such a request.
    Assuming one multiple distributor receives one request in a year 
from both a manufacturer and FDA, the agency estimates the multiple 
distributor would need from 3 to 4 days, or a median of 3.5 days, to 
comply.
    7. Section 821.30(d) requires distributors, final distributors, or 
multiple distributors to make available for auditing, upon a 
manufacturer's written request, records required under this tracking 
regulation. FDA is unaware of manufacturers making written audit 
requests. However, distributors, final distributors, and multiple 
distributors do incur a burden in responding to manufacturer requests 
to verify data under manufacturer auditing of tracking system data. FDA 
assumes most such data verification is accomplished by telephone during 
``distributor audit responses,'' which includes responses from final 
distributors and multiple distributors as well.
    FDA's estimate of the burden for distributor audit responses 
assumes: Manufacturers audit data base entries for 5 percent of tracked 
devices distributed; entries in tracking system data bases approximate, 
in number and amount, data reported by distributors (data reports); 
and, each audited data base entry prompts one distributor audit 
response. FDA estimates that all distributors will take 10 minutes 
(0.1666 hours) to verify data. FDA allows that 10 percent of audited 
data might be found noncompliant, i.e., discrepant, and would require 
further followup responses from distributors to confirm, correct, or 
update data.
    Distributor audit responses for tracked implants: Certain final 
distributors that handle tracked implants would be asked by 
manufacturers to verify data for 5 percent of the total number of 
implants actively tracked (``total tracked'' implants in table 7 of 
this document= ``new implants'' + ``previous implants'' in table 4 of 
this document). Data for dura mater and AAA stent grafts must be 
audited twice a year because the devices are in the first 3 years of 
tracking (see 21 CFR 821.25(c)(3)). FDA adjusts for these devices by 
factoring in the percentage they constitute of ``total tracked'' 
devices (shown in table 7 of this document). Data for all other tracked 
implants are audited once a year.
    For 1999 to 2001, the average number of ``total tracked'' implants 
tracked per year amounts to 3,214,549 devices, as estimated per tables 
4 and 7 of this document as follows: 491,339 + 2,203,603 devices (for 
1999) + 516,166 + 2,694,942 devices (for 2000) + 526,489 + 3,211,108 
devices for (2001) <divide> 3. The average annual burden for 
distributor audit responses regarding data for tracked implants, 
audited once a year, is estimated as: 3,214,549 devices (average number 
of ``total tracked'' implants) x 1 data report per device from final 
distributors x 1 data base entry per data report x .05 (percentage of 
data base entries audited) x .996 (percentage of entries audited once a 
year) x 1 distributor audit response per audited record x 0.1666 hours 
(10 minutes) per response = 26,678 hours.
    Adding 10 percent for additional responses to followup verification 
of noncompliant data increases the burden to 29,346 hours. Applying the 
above formula to the 0.37 percent (average percentage) of total tracked 
implants whose data are audited twice a year results in an additional 
635 burden hours (includes 10 percent for additional followups).
    Distributor audit responses for tracked l/s-l/s devices: 
Distributors and multiple distributors of three types of tracked l/s-l/
s devices, that is, breathing frequency (infant apnea) monitors, 
continuous ventilators, and DC-defibrillators would be asked to verify 
audited data for these devices. Only the data for ``new devices'' 
distributed each year would be audited. For 1999 to 2001, the average 
number of ``new devices'' of these three types of tracked l/s-l/s 
devices would be 160,144 devices, as estimated per table 6 of this 
document as follows: 128,157 devices (for 1999) + 157,702 devices (for 
2000) + 194,572 devices (for 2001) <divide> 3.
    The average annual burden for distributor audit responses regarding 
data for these three types of tracked l/s-l/s devices would be: 160,144 
devices (average number of ``new devices'' distributed per year) x 2 
data reports per device (based on mean number of distributors or 
multiple distributors in distribution chains) x 1 data base entry per 
distributor data report x .05 (percentage of entries audited) x 1 
distributor audit response per audited record x 0.1666 hours per 
response = 2,668 hours. Adding 10 percent for additional responses to 
verify

[[Page 24155]]

noncompliant data increases the burden to 2,935 hours.
    For 1999 to 2001, the average number of ``total units''(table 5 of 
this document), and ``new devices'' (table 6 of this document), of 
tracked electromechanical infusion pumps distributed per year would be 
93,892 ``new devices,'' as estimated per table 6 as follows: 86,600 
devices (for 1999) + 93,400 devices (for 2000) + 101,676 devices (for 
2001) <divide> 3. The average annual burden for distributor audit 
responses regarding data for electromechanical infusion pumps that are 
tracked l/s-l/s devices is estimated as: 93,892 devices (average number 
of ``new devices'') x 3 reports (based on mean number of distributors 
or multiple distributors) x 1 data base entry x .05 entries audited x 1 
distributor response x 0.1666 hours = 2,346 hours. Adding 10 percent 
for additional followup responses by distributors increases the burden 
to 2,581 hours.

                                         Table 7.--Tracked Implants: Estimated Distribution and Audit Frequency
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                          Tracked Since 1994                  Tracked Since 1999
                 End of Year                    Total Tracked    Percent Audited -----------------------------------------------------------------------
                                                                                  Percent of Total   Audits per Year  Percent of Total   Audits per Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
1994                                            393,000                5%               100.0%              2               n/a               n/a
1995                                            805,000                5%               100.0%              2               n/a               n/a
1996                                          1,262,000                5%               100.0%              2               n/a               n/a
1997                                          1,728,140                5%               100.0%              1               n/a               n/a
1998                                          2,203,603                5%               100.0%              1               n/a               n/a
1999\1\                                       2,694,942                5%                99.8%              1                 0.2%              2
2000\2\                                       3,211,108                5%                99.6%              1                 0.4%              2
2001                                          3,737,598                5%                99.5%              1                 0.5%             2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Procedural data for dura mater is included in the 1999 through 2001 estimates.
\2\ Procedural data for abdominal aortic aneurysm stent grafts is included in the 2000 through 2001 estimates.

    8. Under Sec. 821.25(b) manufacturers must maintain current 
tracking records in accordance with standard operating procedures 
(SOP's). To maintain data bases, manufacturers conduct 
``transactions,'' such as receiving data from distributors (distributor 
data reports), registering patients, making data base entries, and 
auditing entries against distributor data. Audit activities are 
estimated separately (Sec. 821.25(c)(3)).
    Data base for tracked implants: For this estimate, and in FDA's 
``Cost Assessment'' (Ref. 1), FDA uses a consulted implant 
manufacturer's estimate that his firm conducts some 2.5 data base 
transactions at a cost of about $5 per transaction. Using a composite 
wage rate of $17.25 for involved personnel, each transaction costing $5 
would take personnel approximately 17 minutes (0.2899 hour) to 
complete. For 1999 to 2001, the average number of ``total tracked'' 
implants actively tracked per year amounts to 3,214,549 devices, as 
estimated per table 7 of this document as follows: 2,694,942 devices 
(for 1999) + 3,211,108 devices (for 2000) + 3,737,598 devices (for 
2001) <divide> 3. The average annual burden for data base transactions 
for tracked implants is estimated as: 3,214,549 (average number of 
``total tracked'' implants) x 2.5 data base transactions per year x 
0.2899 hours per transaction = 2,329,744 hours.
    Data base for tracked l/s-l/s devices: For three types of tracked 
l/s-l/s devices, i.e., tracked breathing frequency monitors, continuous 
ventilators, and DC-defibrillators, the average annual burden for data 
base transactions would be: 160,144 devices (average number of ``new 
devices'' distributed per year) (128,157 devices (for 1999) + 157,702 
devices (for 2000) + 194,572 devices (for 2001) <divide>3, per table 6 
of this document) x 2 distributors or multiple distributors per device 
(based on the mean number in distribution chains) x 1 data report per 
distributor x 1 data base transaction per report x 0.2899 hour (17 
minutes) per transaction = 92,851 hours.
    For one type of tracked l/s-l/s device, i.e., electromechanical 
infusion pumps, the average annual burden would be: 93,892 devices 
(average number of ``new devices'' distributed per year) (86,600 
devices (for 1999) + 93,400 devices (for 2000) + 101,676 devices (for 
2001) <divide> 3, per table 6) x 3 distributors or multiple 
distributors x 1 data report x 1 transaction x 0.2899 hour per 
transaction = 81,658 hours.

[[Page 24156]]

    9. Under Sec. 821.25(c), manufacturers must establish SOP's for 
collecting, maintaining, and auditing tracking data.
    Two dura mater manufacturers and one AAA stent graft manufacturer 
would have one-time burdens. FDA estimates these three firms would take 
an average of two staff months to plan and develop a tracking system, 
and one month to draft and implement standard operating procedures 
(SOP's), including the development of audit SOP's. This amounts to 
1,584 hours (3 firms x 3 months x 22 working days per month x 8 hours 
per day). There would be no such burdens for 204 manufacturers that 
have had tracking systems in place since 1993.
    Manufacturers with tracking systems in place would review and/or 
revise their tracking system SOP's on an annual basis, expending 
approximately 10 percent of the amount of time spent originally in 
drafting the SOP's, i.e., 22 days x 8 hours per day = 18 hours. Over 
the 3 years, 1999 to 2001, 617 firms would annually revise tracking 
SOP's as follows: 204 firms (excludes dura mater firms) for 1999, 206 
firms (includes 2 dura mater firms, excludes 1 AAA stent firm) for 
2000, and 207 firms (includes all) for 2001. The total annual burden 
for revising SOP's for 3 years would amount to: 617 firms x 18 hours 
per firm = 11,106 hours.
    For 1999 to 2001, the average total annual burden (annualized 
burden) would be 4,236 hours: 1, 584 hours (total one time burdens) + 
11,106 hours (total annual burdens) <divide> 3 years.
    10. Section 821.25(c)(3) requires that the auditing SOP of 
manufacturers include a quality assurance program that has audit 
procedures to be run for each tracked device product for the first 3 
years of distribution and once a year thereafter. As discussed under 
Sec. 821.30(d), FDA's burden estimate for manufacturer auditing assumes 
firms would audit 5 percent of records for products, based on numbers 
of devices actively tracked (implants) each year, or distributed 
(tracked l/s-l/s devices) each year. Tracking data base entries, 
corresponding in numbers and kind, to distributor data reports (and, 
for tracked implants, implanted patient reports) would be verified by 
phone through distributor data responses or patient contacts. FDA 
provides for 10 percent further followups for noncompliance, i.e., to 
change inaccurate or update data. Burdens are estimated for auditing 
data for tracked implants and tracked l/s-l/s products as follows 
below.
    Manufacturer auditing for tracked implants: Using the same $5 per 
tracking ``transaction'' figure that was used for data base maintenance 
estimates, FDA assumes auditing transactions would take 17 minutes 
(0.2899 hours). Manufacturers would audit data for ``total tracked'' 
implants, as shown in table 7 of this document. ``Total tracked'' 
implants correspond to amounts actively tracked each year (``new 
implants'' + ``previous implants'' in table 4 of this document) and 
take into account devices distributed in previous years that are 
implanted and continue to be tracked for 8 subsequent years, the 
approximate lifetime of implants that FDA uses.
    On average, about 99.63 percent (99.8 percent (for 1999) + 99.6 
percent (for 2000) + 99.5 percent (for 2001) <divide> 3, per table 7 of 
this document) of the data audited (i.e. 5 percent of the total data 
base entries corresponding to the average number of total tracked 
devices for 1999 to 2001) would be audited once a year and 10 percent 
of this data would be further audited. On average, about .37 percent of 
the 5 percent of data base entries audited (the approximate amount 
comprised by data base entries for dura mater and AAA stents) would be 
audited twice.
    For 1999 to 2001, the average annual burden for auditing tracked 
implants requiring one audit per year would be: 3,214,549 devices 
(average number of ``total tracked'' implants actively tracked each 
year) (2,694,942 devices (for 1999) + 3,211,108 devices (for 2000) + 
3,737,598 devices (for 2001) <divide> 3, per table 7 of this document) 
x 1 final distributor data report per ``new implant'' upon implantation 
(or 1 implanted patient report per ``previous implant'' distributed) 
per data base entry x .05 (percentage of data base entries audited) x 
.996 (average percentage of entries audited once per year) x .2899 
hours (17 minutes) per audit transaction = 46,423 hours. Adding 10 
percent for followup auditing increases the burden to 51,065 hours.
    Applying the above formula to data base entries for tracked 
implants requiring 2 audits per year (an average .0037 of total tracked 
devices) results in 345 hours. A 10 percent additional followup rate 
makes 380 burden hours.
    Manufacture auditing for tracked l/s-l/s devices: For breathing 
frequency (infant apnea) monitors, continuous ventilator, and DC-
defibrillators the data for ``new devices'' distributed each year would 
be audited. For 1999 to 2001, the average annual burden for these 
devices would be: 160,144 devices (average number of ``new devices'' 
distributed per year) (128,157 devices (for 1999) + 157,702 devices 
(for 2000) + 194,572 devices (for 2001) <divide> 3, per table 6 of this 
document) x 2 data reports per device (based on the mean of the number 
of distributors or multiple distributors in distribution chains) x 1 
data base entry per distributor or multiple distributor data report x 
.05 (percentage of entries audited) x .2899 hours = 4,642 hours.

[[Page 24157]]

Adding 10 percent for additional followup results in 5,106 hours.
    Applying the above formula to 93,892 electromechanical infusion 
pumps that are tracked l/s-l/s devices (average number of ``new 
devices''), having a mean of three distributors or multiple 
distributors, would result in 4,083 hours. A 10 percent additional 
audit rate makes 4,491 hours.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(d)), the agency has submitted the information collection 
provisions of this proposed rule to OMB for review. Interested persons 
are requested to send comments regarding information collection by May 
25, 2000, to the Office of Information and Regulatory Affairs, OMB 
(address above).

IX. References

    The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. ``Cost Assessment of Medical Device Tracking,'' Economics Staff, 
Food and Drug Administration, 1999.

List of Subjects in 21 CFR Part 821

    Imports, Medical devices, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, FDA proposes 
to amend part 821 to read as follows:

PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

    1. The authority citation for 21 CFR part 821 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 
374.
    2. Section 821.1 is amended by revising paragraphs (a) and (b); by 
removing paragraph (c); and by redesignating paragraphs (d) and (e) as 
paragraphs (c) and (d), respectively, to read as follows:


Sec. 821.1  Scope.

    (a) The regulations in this part implement section 519(e) of the 
Federal Food, Drug and Cosmetic Act (the act), which provides that the 
Food and Drug Administration may by order require a manufacturer to 
adopt a method of tracking a class II or class III device, the failure 
of which would be reasonably likely to have serious adverse health 
consequences, or which is intended to be implanted in the human body 
for more than 1 year, or which is a life-sustaining or life-supporting 
device used outside a device user facility. A device required by FDA 
order to be tracked is subject to this part and is referred to herein 
as a tracked device.
    (b) These regulations are intended to ensure that tracked devices 
can be traced from the device manufacturing facility to the person for 
whom the device is indicated, that is, the patient. Effective tracking 
of devices from the manufacturing facility, through the distributor 
network (including distributors, retailers, rental firms and other 
commercial enterprises, device user facilities, and licensed 
practitioners) and, ultimately, to any person for whom the device is 
intended is necessary for the effectiveness of remedies prescribed by 
the act, such as patient notification (section 518(a) of the act) or 
device recall (section 518(e) of the act). Although these regulations 
do not preclude a manufacturer from involving outside organizations in 
that manufacturer's device tracking effort, the legal responsibility 
for complying with this part rests with manufacturers who are subject 
to tracking orders, and that responsibility cannot be altered, 
modified, or in any way voided by contracts or other agreements.
* * * * *


Sec. 821.2  [Amended]

    3. Section 821.2 Exemptions and variances is amended by removing 
paragraph (d).
    4. Section 821.3 is amended by revising paragraphs (b) and (f) to 
read as follows:


Sec. 821.3  Definitions.

* * * * *
    (b) Importer means the initial distributor of an imported device 
who is subject to a tracking order. ``Importer'' does not include 
anyone who only furthers the marketing, i.e., brokers, jobbers, or 
warehousers.
* * * * *
    (f) Device intended to be implanted in the human body for more than 
1 year means a device that is intended to be placed into a surgically 
or naturally formed cavity of the human body for more than 1 year to 
continuously assist, restore, or replace the function of an organ 
system or structure of the human body throughout the useful life of the 
device. The term does not include any device which is intended and used 
only for temporary purposes or which is intended for explantation in 1 
year or less.
* * * * *
    5. Section 821.20 is amended by revising paragraph (a), by removing 
paragraphs (b) and (c), by redesignating paragraph (d) as paragraph 
(b), and by revising newly redesignated paragraph (b) to read as 
follows:


Sec. 821.20  Devices subject to tracking.

    (a) When required by a tracking order issued by FDA, a manufacturer 
of any class II or class III device, the failure of which would be 
reasonably likely to have a serious adverse health consequence, or 
which is intended to be implanted in the human body for more than a 
year, or which is life-sustaining or life-supporting and used outside a 
device user facility, shall track that device in accordance with this 
part.
    (b) When responding to premarket notification submissions and 
approving premarket approval applications, FDA will notify the sponsor 
by issuing a tracking order that states that FDA believes the device 
meets the criteria of section 519(e)(1) of the act and, by virtue of 
the order, is required to be tracked.
    6. Section 821.25 is amended by revising the introductory text of 
paragraph (a)(2), paragraph (a)(2)(iii), the introductory text of 
paragraph (a)(3), and paragraph (a)(3)(iv) to read as follows:


Sec. 821.25  Device tracking system and content requirements: 
manufacturer requirements.

    (a) * * *
    (2) Within 10 working days of a request from FDA for tracked 
devices that are intended for use by a single patient over the life of 
the device, after distribution to or implantation in a patient:
* * * * *
    (iii) The name, address, telephone number, and social security 
number (if available) of the patient receiving the device, unless not 
released by the patient under Sec. 821.55(a);
* * * * *
    (3) Except as required by order under section 518(e) of the act, 
within 10 working days of a request from FDA for tracked devices that 
are intended for use by more than one patient, after the distribution 
of the device to the multiple distributor:
* * * * *
    (iv) The name, address, telephone number, and social security 
number (if available) of the patient using the device, unless not 
released by the patient under Sec. 821.55(a);
* * * * *


Sec. 821.30  [Amended]

    7. Section 821.30 Tracking obligations of persons other than device 
manufacturers: distributor requirements is amended in paragraphs (b)(3) 
and

[[Page 24158]]

(c)(1)(ii) by removing the semicolon at the end of each paragraph and 
adding in its place ``, unless not released by the patient under 
Sec. 821.55(a);''.
    8. Section 821.55 is amended by redesignating paragraphs (a) and 
(b) as paragraphs (b) and (c), respectively, and by adding paragraph 
(a) to read as follows:


Sec. 821.55  Confidentiality.

    (a) Any patient receiving a device subject to tracking requirements 
under this part may refuse to release, or refuse permission to release, 
the patient's name, address, telephone number, and social security 
number, or other identifying information for the purpose of tracking.
* * * * *

    Dated: February 14, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-10251 Filed 4-24-00; 8:45 am]
BILLING CODE 4160-01-F