[Federal Register Volume 67, Number 27 (Friday, February 8, 2002)]
[Rules and Regulations]
[Pages 5943-5952]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-3076]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the medical 
device tracking regulation. FDA is making substantive changes to revise 
the scope of the regulation and add certain patient confidentiality 
requirements, and nonsubstantive changes to remove outdated references 
and simplify terminology. These revisions are made to conform the 
regulation 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), and to simplify certain requirements.

DATES: This rule is effective May 9, 2002. The information collection 
provisions of this final rule have been submitted to the Office of 
Management and Budget (OMB) for review. Prior to the effective date of 
this final rule, FDA will publish in the Federal Register a notice 
announcing OMB's decision to approve, modify, or disapprove the 
information collection provisions in this final rule.

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. Current Statutory Tracking Provisions (As Amended by FDAMA)

    Section 211 of FDAMA (Public Law 105-115) became effective on 
February 19, 1998. It amended the previous tracking provisions in 
section 519(e)(1) and (e)(2) of the act (21 U.S.C. 360i(e)(1) and 
(e)(2)) that were added by the Safe Medical Devices Act (SMDA). Unlike 
the tracking provisions under SMDA, which required tracking for any 
device meeting certain criteria, FDAMA allows FDA discretion in 
applying tracking requirements to devices that meet certain criteria 
and provides that tracking requirements can be imposed only after FDA 
issues an order.
    Current section 519(e)(1) of the act, as amended by FDAMA, provides 
that FDA may by order require a manufacturer to adopt a method of 
tracking a class II or class III device if: (1) Its failure would be 
reasonably likely to have serious adverse health consequences, or (2) 
it is intended to be implanted in the human body for more than 1 year, 
or (3) it is a life-sustaining or life-supporting device used outside a 
device user facility. FDA interprets the discretion inherent in the 
language ``may by order require'' tracking to allow the agency to 
consider additional relevant factors in determining whether to issue a 
tracking order for a device that meets the statutory threshold tracking 
criteria set out in current section 519(e)(1) of the act.
    As amended by FDAMA, current section 519(e)(2) of the act provides 
that patients receiving a device subject to

[[Page 5944]]

tracking may refuse to release, or refuse permission to release, their 
names, addresses, social security numbers, or other identifying 
information for tracking purposes.
    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 FDA 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 (21 U.S.C. 360h(e)) (S. Rept. 108, 105th Cong., 1st 
sess. 37 (1997)).

II. Steps Taken to Implement FDAMA Tracking Authority and Conform 
the Tracking Regulation to Current Tracking Provisions Under FDAMA

A. Implementing Statutory Tracking Authority Under FDAMA

1. Public Meeting/Manufacturer Notification
    In the Federal Register of December 18, 1997 (62 FR 66373), FDA 
announced its intent to conduct a public meeting in Rockville, MD, to 
discuss changes in medical device tracking. This meeting occurred on 
January 15,1998.
    On December 19, 1997, FDA sent letters to manufacturers with device 
tracking responsibilities under section 519(e) of the act. The letters 
explained that FDA would implement statutory changes in medical device 
tracking under FDAMA. The letters advised that existing 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, comments from consumer 
groups, clinicians, manufacturers, and industry associations suggested 
nonbinding factors that FDA should consider, in addition to the 
tracking criteria set out under FDAMA, to determine whether tracking 
should be ordered by FDA.
2. Issuance of Tracking Orders Under FDAMA
    On February 11, 1998, FDA issued orders to manufacturers of 28 
types of devices, which the agency determined met the revised tracking 
criteria in section 519(e) of the act, as amended by FDAMA. These 
``new'' orders became effective on February 19, 1998, the effective 
date of the revised tracking provision under FDAMA. The devices ordered 
to be tracked included 26 device types previously identified as subject 
to tracking under the SMDA criteria in the tracking regulation at 
Sec. 821.20(b)(1), (b)(2), and (c) (21 CFR 821.20(b)(1), (b)(2), and 
(c)). Arterial stents and intraocular lenses, which had not been listed 
previously as subject to tracking in the regulation, also were ordered 
to be tracked under FDAMA.
3. Rescission of Certain Tracking Orders Issued Under FDAMA
    Beginning on August 26, 1998, FDA rescinded the tracking orders 
issued on February 19, 1998, for 14 types of devices, including 
intraocular lenses and arterial stents.
    FDA determined, in light of its discretionary authority under 
FDAMA, that these 14 device types did not warrant continued tracking 
based on additional factors, even though the statutory criteria were 
met. The additional and nonbinding factors FDA considered included: (1) 
The likelihood of sudden, catastrophic failure; (2) the likelihood of 
significant adverse clinical outcomes; and (3) the need for prompt 
professional intervention.
4. Issuance of Additional FDAMA Tracking Orders
    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.
    On September 28, 1999, FDA issued orders to manufacturers of stent 
grafts intended to treat abdominal aortic aneurysms (AAA), requiring 
them to track the devices.
    Upon reviewing premarket applications, the agency determined these 
devices met the statutory tracking criteria of amended section 519(e) 
of the act, because their failure would be reasonably likely to have 
serious adverse consequences, and also would necessitate prompt 
professional intervention.
    In April, August, and October 2000, FDA issued tracking orders to 
seven firms that received agency clearance to market devices of the 
type the agency had already subjected to the tracking requirement. 
Three of these firms had not tracked devices before. They received FDA 
orders to track the replacement heart valves, temporomandibular joint 
(TMJ) prostheses, and continuous ventilators they marketed, as other 
firms had been ordered to do before them. The four other firms were 
already tracking other models of the cardiovascular permanently 
implantable pacemaker electrodes and continuous ventilators that they 
were ordered to track in 2000.
5. Availability of Informative Notices and Explanatory Guidance 
Documents
    FDA published a series of Federal Register notices that updated 
tracking information or announced the availability of further guidance 
documents. These notices and guidance documents were made available to 
the public at the agency Web site, http://www.fda.gov/cdrh/
fedregin.html. They were as follows:
    a. 63 FR 10638, March 4,1998--FDA issued a notice announcing its 
issuance on February 11, 1998, of new tracking orders under its new 
authority under FDAMA. These new orders became effective on February 
19, 1998, and made 28 types of devices manufactured by specific firms 
subject to the tracking requirements of section 519(e) of the act, as 
amended under FDAMA. FDA also announced its intention to exercise its 
new discretionary authority under FDAMA. The agency advised that it 
would identify additional nonbinding factors to determine whether 
tracking requirements, and the issuance of agency tracking orders, were 
warranted for devices that otherwise qualify to be tracked under 
section 519(e)(1) of the act criteria.
    This notice announced FDA's intention to review and reconsider the 
imposition of tracking requirements for 13 devices that were identified 
as meeting the threshold statutory criteria and that were subject to 
February 1998 tracking orders. FDA solicited public comment on which 
nonbinding factors it should consider in making such discretionary 
tracking determinations.
    b. 63 FR 10640, March 4, 1998--FDA issued a notice announcing the 
availability of the guidance document entitled ``Guidance on Medical 
Device Tracking.'' 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 which statutory and 
regulatory requirements had changed, and which requirements remained 
the same. The guidance represented FDA's thinking at that time on 
medical device tracking under the FDAMA amendments.
    c. 64 FR 7197, February 12, 1999--FDA issued a notice announcing 
the availability of the revised final guidance document entitled 
``Guidance on Medical Device Tracking.'' It replaced the previous 
guidance issued on March 4, 1998.
    The revised February 1999 guidance noted FDA's December 1998 
issuance of

[[Page 5945]]

tracking orders for dura mater devices and provided an updated list of 
devices that were subject to tracking orders. It also identified the 
additional nonbinding factors that FDA may use, in addition to the 
statutory criteria, to decide whether to require the tracking of a 
device. The factors mentioned included: The likelihood of sudden, 
catastrophic failure or significant, adverse clinical outcomes, and the 
need for prompt professional intervention.
    d. 64 FR 3722, January 24, 2000--FDA issued a notice announcing the 
availability of an updated and revised ``Guidance on Medical Device 
Tracking'' that both reaffirmed previous agency positions regarding 
FDAMA revised tracking requirements and clarified current thinking 
regarding certain devices subject to tracking requirements.
    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. The January 2000 guidance stated that FDA 
reevaluated the tracking status of infusion pumps because their 
labeling does not always make clear the types of fluids the pumps are 
intended to deliver.
    Infusion pump labeling statements became an issue when the previous 
February 1999 guidance document identified infusion pumps as devices 
subject to tracking, ``except those designated and labeled for use 
exclusively for fluids with low potential risks, such as enteral 
feeding or anti-infectives.'' FDA experience, upon reexamination, was 
that most infusion pumps have labeling that is general in nature, i.e, 
they are intended ``to deliver medications,'' and very few pumps are 
labeled with a specific indication. Thus, there was uncertainty whether 
product labels would provide sufficient information to determine which 
infusion pumps must be tracked.
    To reduce the above uncertainties and clarify FDA's position, the 
January 2000 guidance stated that tracking is required only for 
electromechanical infusion pumps used outside device user facilities. 
Thus, FDA's current position is that tracking is not needed for 
elastomeric, electromechanical, gravity flow, and other infusion pumps 
used in hospitals and other device user facilities. This also means 
that FDA does not consider tracking warranted for elastomeric and 
gravity flow pumps used outside device user facilities, based on the 
regulatory history of these products. A firm may request a tracking 
variance or exemption under Sec. 821.2 (21 CFR 821.2) for an 
electromechanical infusion pump used outside a device user facility if 
the firm can demonstrate that the pump is labeled and used solely to 
administer fluids with low potential risks.

B. Proposed Rule Amending Current Tracking Regulation

    In the Federal Register of April 25, 2000 (65 FR 24144), FDA 
published a proposal to amend the existing medical device tracking 
regulation part 821 (21 CFR part 821) to conform to statutory changes 
made by FDAMA in the scope, authority, criteria, and confidentiality 
requirements of tracking. FDA proposed:
     Revising the existing scope and authority set out in 
Secs. 821.1 and 821.20;
     Modifying existing definitions of ``importer'' 
(Sec. 821.3(b)) and ``permanently implantable device'' (Sec. 821.3(f));
     Removing existing criteria, responsibilities, and 
authority from Sec. 821.20(b)(1), (b)(2), and (c); and
     Adding new patient confidentiality provisions in new 
Sec. 821.55(a), and references to new Sec. 821.55(a) to existing 
Sec. 821.30(b)(3) and (c)(1)(iii).
    For simplification, FDA further proposed nonsubstantive changes to 
remove unneeded references to the 1993 effective date of tracking 
provisions in Sec. 821.1(c), and to outdated procedures for citizen 
petitions received before August 29, 1993, in Sec. 821.2(d). FDA also 
proposed substituting the simple inclusive term ``tracked devices'' to 
replace the more complex detail describing devices subject to tracking 
in existing Sec. 821.25(a)(2) and (a)(3).
    FDA did not propose changes in parts of the existing regulation 
that were not affected by FDAMA. Except for the nonsubstantive changes 
described above, FDA did not propose changes in the regulation with 
respect to: Existing system and content requirements for tracking; 
existing obligations of persons other than device manufacturers, such 
as distributors; existing records and inspection requirements; and 
existing record retention requirements.

III. Public Comment on Proposal to Amend Tracking Regulation

    FDA received just one comment on its April 25, 2000 (65 FR 24144 at 
24145), proposal. The comment came from a device firm. It identified a 
reference in the preamble of the proposal to clarifications made by FDA 
concerning infusion pumps subject to tracking. FDA had discussed which 
infusion pumps are covered by the tracking orders it issued, under 
FDAMA, in nonbinding guidance documents that the agency made available 
to the public on February 12, 1999 (64 FR 7197), and an updated and 
revised version that FDA made available on January 24, 2000 (65 FR 
3722).
    The comment maintained that infusion pumps should be tracked on the 
basis of high-risk uses (per FDA's February 1999 guidance) rather than 
on operating technology, i.e., whether or not they are 
electromechanical infusion pumps (per FDA's January 2000 guidance). The 
comment claimed that FDA's position in the January 2000 guidance ``* * 
* would, again, make enteral feeding pumps which are electromechanical 
in nature, subject to tracking, while unfairly exempting enteral 
feeding pumps which are not electromechanical.''
    The issue raised by the comment is outside the scope of the 
regulation. Specifically, the comment relates to the appropriateness of 
the issuance of orders that were issued under section 519(e) of the act 
as amended by FDAMA, prior to the existence of this proposed 
regulation. The comment also relates to the appropriateness of guidance 
that was published prior to the existence of this proposed regulation. 
Since the issuance of these orders relating to infusion pumps took 
place under authority that was independent of the proposed regulation, 
the appropriateness of the order's issuance is not within the scope of 
this regulation.
    FDA does note, however, that in describing the criteria for 
triggering the issuance of the future orders that will be issued under 
the regulation, the regulation mirrors the language of the statute. If 
it has concerns about the issuance of previous orders relating to 
infusion pumps, the firm may request an exemption from the tracking 
regulations, and may also submit comments on the guidance relating to 
the application of tracking requirements to infusion pumps.

IV. Corrective Changes to Tracking Regulation

A. Summary of Changes

    On February 19, 1998, FDAMA amended section 519(e) of the act. By 
operation of statute, certain provisions in the current tracking 
regulation, part 821, became inconsistent with the tracking 
requirements as revised by FDAMA. On April 25, 2000, FDA published in 
the Federal Register (65 FR 24144) a proposal to amend the existing 
medical device tracking regulation (part 821) to conform to statutory 
changes made by FDAMA in

[[Page 5946]]

the scope, authority, criteria, and confidentiality requirements of 
tracking.
    This final rule incorporates, unchanged, all of the proposed 
revisions that the agency set out in its April 25, 2000, proposal to 
amend the existing regulation. In particular, the final rule revises 
certain sections of part 821 to conform to section 519 of the act, as 
amended. Thus, FDA is revising 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.
    Other than the final changes described above, parts of the tracking 
regulation that were not affected by FDAMA remain unchanged. Except for 
the nonsubstantive terminology change noted above, this final rule 
makes no revisions to:
     The regulation's existing system and content tracking 
requirements,
     The current obligations of persons other than device 
manufacturers, such as distributors,
     Records and inspection requirements, and
     Existing record retention requirements.
    Each of the revisions made by this final rule amending the existing 
medical devices tracking regulation is discussed in more detail below.

B. Scope (Sec. 821.1) 

Conformance With FDAMA Tracking Criteria
    1. FDA is amending Sec. 821.1 by revising paragraph (a) to conform 
its language to the statutory language in section 519(e) of the act, as 
amended by FDAMA.
    Under FDAMA, the types of persons subject to tracking are no longer 
linked to registration requirements under section 510 of the act (21 
U.S.C. 360). As amended, the tracking requirements apply only to 
manufacturers who receive a tracking order from FDA.
    FDAMA modifies the criteria for tracking devices. In revised 
section 519(e)(1) of the act amended by 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 one year, or (ii) a life sustaining or 
life supporting device used outside a device user facility.''
    FDAMA allows FDA to exercise discretion in determining whether a 
device that meets the criteria in section 519(e) of the act shall be 
tracked. This means that, even if the statutory criteria are met, 
tracking is not required unless FDA issues an order that directs a 
manufacturer to track a device. Under FDAMA, the statutory criteria 
establish a minimum threshold. If the device does not meet any of the 
criteria in section 519(e) of the act, FDA may no longer designate a 
device as one that requires tracking to protect the public health.
    Accordingly, to conform the language in Sec. 821.1(a) to the 
statutory language in current section 519(e) of the act, FDA is 
amending section 519(a) to read as follows:

    ``The regulations in this part implement section 519(e) of the 
Federal Food, Drug, and Cosmetic Act, which provides that the Food 
and Drug Administration may require a manufacturer to adopt a method 
of tracking a class II or class III device, if the device meets one 
of the following three criteria and FDA issues an order to the 
manufacturer: the failure of the device would be reasonably likely 
to have serious adverse health consequences; or the device is 
intended to be implanted in the human body for more than 1 year; or 
the device is a life-sustaining or life-supporting device used 
outside a device user facility. A device that meets one of these 
criteria and is the subject of an FDA order must comply with this 
part and is referred to, in this part, as a `tracked device.' ''
Eliminating the Linkage of Tracking to the Registration of a Person as 
the Manufacturer of a Device
    2. FDA is revising 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) of the 
act by FDAMA. The revised tracking requirements, as amended by FDAMA, 
are triggered for the manufacturer by the issuance of an FDA tracking 
order, not by registration requirements. For clarity, FDA is also 
revising the second sentence in paragraph (b) in Sec. 821.1 by removing 
the words ``any person for whom the device is intended'' and 
substituting the words ``the patient.''
Removing Outdated Requirement
    3. FDA is amending Sec. 821.1 by removing paragraph (c). Section 
821.1(c) was included in the final tracking regulations issued in 1993 
to clarify that the effective date for the tracking requirements under 
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.
Redesignation of Paragraphs in Sec. 821.1 (Without Revision)
    4. In conjunction with the removal of paragraph (c) from 
Sec. 821.1, FDA is redesignating current paragraphs (d) and (e) in this 
section as paragraphs (c) and (d), respectively. No changes are made in 
these redesignated paragraphs.

C. Exemptions and Variances (Sec. 821.2)

    5. FDA is amending Sec. 821.2 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 FDA has responded to all of those petitions, there 
is no longer any need to include deadlines and timeframes for these 
particular petitions.

D. Definitions (Sec.  821.3)

    6. FDA is revising the definition of ``Importer'' in existing 
Sec. 821.3(b). ``Importer'' was previously 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 removing the existing 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 replacing it with the 
phrase ``subject to a tracking order.'' For tracking purposes, this 
change makes the term ``Importer'' mean ``the initial distributor of an 
imported device who is subject to a tracking order.'' For clarity, FDA 
is also revising the phrase ``who only performs a service for the 
person who furthers the marketing,'' to ``who only furthers the 
marketing.''
    Accordingly, this final rule amends Sec. 821.3(b) to read as 
follows:
    ``(b) Importer means the initial distributor of an imported device 
that is subject to a tracking order. ``Importer'' does not include 
anyone who only furthers the marketing, e.g., brokers, jobbers, or 
warehousers.''
    7. FDA is amending Sec. 821.3(f) by revising the definition of 
``Permanently implantable device.'' Previously, Sec. 821.3(f) defined 
``Permanently implantable device'' as meaning ``a device that is 
intended to be placed into a surgically or naturally formed cavity of 
the human body 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

[[Page 5947]]

any device which is intended and used for temporary purposes or which 
is intended for explantation.''
    FDAMA amended section 519(e)(1)(B)(i) of the act to provide that 
FDA only may order tracking of an implanted device if the device ``is 
intended to be implanted in the human body for more than 1 year.'' 
Thus, FDA is changing 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.''
    FDA is also adding the phrase ``for more than 1 year'' in the first 
sentence of the revised definition after the phrase ``of the human 
body.'' And, at the end of the second sentence, FDA is adding the 
phrase ``in 1 year or less.'' These latter two revisions further 
incorporate into the revised definition the minimum implantation time 
period established 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, in revised Sec. 821.3(f), FDA is retaining 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.
    Accordingly, FDA is amending Sec. 821.3(f) to read as follows:
    ``(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 that is intended 
and used only for temporary purposes or that is intended for 
explantation in 1 year or less.''

E. Devices Subject to Tracking (Sec. 821.20)

Revisions, Removals, and Redesignation
    8. FDA is amending Sec. 821.20 by revising paragraph (a), by 
removing paragraphs (b) and (c), by redesignating paragraph (d) as 
paragraph (b), and by revising newly redesignated paragraph (b).
Revision for Conformance
    9. FDA is revising paragraph (a) to conform Sec. 821.20(a) to the 
tracking provision of section 519(e) of the act, as amended by FDAMA. 
The existing paragraph (a) conformed to the tracking provision that was 
added to the act under section 519(e) by SMDA. That earlier version of 
section 519(e) of the act required the tracking of devices that met the 
statutory tracking criteria for devices in section 519(e) and 
manufacturers made the initial determination whether their devices met 
the statutory criteria for tracking. It also required the tracking of 
devices that FDA, in its discretion, designated as requiring tracking.
    FDA is revising paragraph (a) of Sec. 821.20 to conform its 
language to the statutory language of the revised section 519(e) of the 
act under FDAMA. Accordingly, amended Sec. 821.20(a) requires 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 the device is:
     One the failure of which would be reasonably likely to 
have serious adverse health consequences, or
     One which is intended to be implanted in the human body 
for more than a year, or
     One which is life-sustaining or life-supporting and used 
outside a device user facility, and is
     One which warrants tracking.
Removal of Illustrative Device Lists
    10. In the amended regulation, FDA is revising Sec. 821.20, 
further, by removing paragraphs (b) and (c).
    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. FDAMA authorizes FDA 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.
    Introductory paragraph (b) and paragraph (b)(1) are being removed 
because it is no longer necessary to give manufacturers guidance about 
how to decide whether they should initiate tracking. Under the 
revisions to section 519(e) of the act by FDAMA, manufacturers no 
longer need to determine whether their devices are subject to tracking. 
Instead, FDA makes the determination by order.
Designated Device Lists
    11. In the amended regulation, FDA has removed paragraph (c) of 
Sec. 821.20. That paragraph, which identified devices FDA designated 
for tracking that did not meet the mandatory tracking criteria under 
SMDA, is no longer relevant. As amended by FDAMA, section 519(e)(2) of 
the act no longer allows FDA to designate for tracking devices that do 
not meet the tracking criteria in section 519(e)(1).
Identifying Tracked Devices to Persons Other Than Manufacturers
    12. Although distributors, final distributors, and multiple 
distributors of tracked devices will not be provided tracking orders, 
as manufacturers are, FDA believes it can keep such interested parties 
apprised of revisions to device types subject to tracking orders 
through the use of guidance or periodic Federal Register notices. FDA 
will make tracking guidance or notices available to interested parties 
through the agency's Internet and Facts-on-Demand Web sites. FDA will 
also announce their availability through the publication of Federal 
Register notices.
    FDA has already disseminated the status and identification of 
tracked devices successfully through Federal Register notices published 
on March 4, 1998 (63 FR 10638 and 63 FR 10640); February 12, 1999 (64 
FR 7197); and January 24, 2000 (65 FR 3722); and through guidance 
documents made available through the Internet on these same dates.
Revising and Redesignating Existing Sec. 821.20(b) and (d).
    13. In removing previous Sec. 821.20(b) and (c) from the 
regulation, FDA is redesignating existing paragraph (d) as paragraph 
(b), and is editing, revising, and deleting provisions of redesignated 
paragraph (b).
    In redesignated Sec. 821.20(b), FDA is revising the language in 
existing Sec. 821.20(d) describing the content of 510(k) and premarket 
approval application orders to reflect the fact that tracking 
requirements are accomplished by order under FDAMA. Revised 
Sec. 821.20(b) reads as follows: ``When responding to premarket 
notification submissions and premarket approval applications, FDA will 
notify the sponsor by issuing an 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, the sponsor must track the device.''

[[Page 5948]]

F. Device Tracking System and Content Requirements: Manufacturer 
Requirements (Sec. 821.25)

Revising Terms Used to Describe Tracked Devices
    14. FDA is amending Sec. 821.25 by revising the terms currently 
used in the introductory texts of paragraphs (a)(2) and (a)(3). The 
term ``tracked device(s)'' replaces existing device descriptions to 
shorten the identification of the types of devices subject to data 
requirements set out under Sec. 821.25(a)(2)(i) through (a)(2)(vii) and 
(a)(3)(i) through (a)(3)(viii). In describing the types of tracked 
devices that were subject to the reporting requirements in 
Sec. 821.25(a)(2)(i) through (a)(2)(vii) and (a)(3)(i) through 
(a)(3)(viii), the existing regulation restated the statutory criteria 
of section 519(e) of the act, as added by the SMDA, that were used to 
subject devices to tracking.
    FDA is amending the introductory text of Sec. 821.25(a)(2) and 
(a)(3) to remove descriptions that reflect SMDA criteria that no longer 
apply.
Revised Terminology
    15. FDA is substituting, in revised Sec. 821.25(a)(2) and (a)(3), a 
description of devices that are subject to reporting requirements that 
is consistent with the section 519(e) of the act criteria as amended by 
FDAMA. To simplify, however, FDA is choosing to use the term ``tracked 
device'' to discuss devices subject to tracking orders under FDAMA, 
rather than to fully restate the revised FDAMA section 519(e) of the 
act criteria for tracked devices.
    FDA revisions of the introductory texts of final Sec. 821.25(a)(2) 
and (a)(3) do not change the data reporting requirements for single 
patient use, implants, or multiple patient use devices that are subject 
to tracking requirements by virtue of the issuance of a FDA tracking 
order.
Refusal of Patients to Provide Information
    16. FDA further amends Sec. 821.25 by revising paragraphs 
(a)(2)(iii) and (a)(3)(iv). These paragraphs previously stated that 
manufacturers must provide ``(t)he name, address, telephone number, and 
social security number (if available) of the patient'' receiving or 
using the device. In this final rule, FDA is revising these paragraphs 
by adding, at the end of each one, the clause ``unless not released by 
the patient under Sec. 821.55(a).''
    These changes conform Sec. 821.25(a)(2)(iii) and (a)(3)(iv) of the 
final regulation to section 519(e)(2) of the act, as amended by FDAMA, 
which 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.

G. Tracking Obligations of Persons Other Than Device Manufacturers: 
Distributor Requirements (Sec. 821.30)

    17. In this final rule, FDA is amending Sec. 821.30 by revising 
paragraphs (b)(3) and (c)(1)(ii) in identical fashion. FDA is changing 
the semicolons at the end of both regulatory requirements to commas. 
FDA then adds the phrase ``unless not released by the patient under 
Sec. 821.55(a);'' following the comma in each requirement.
    These revisions are made in the amended regulation for the reasons 
discussed above under item 16.

H. Confidentiality (Sec. 821.55)

    18. FDA is adding new paragraph (a) to 821.55 for the reasons 
stated above under item 16, and redesignating existing paragraphs (a) 
and (b) as paragraphs (b) and (c), respectively.

V. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this final 
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 final 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 one 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 SMDA 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 to quickly notify all 
distributors, health professionals, or patients of a recall or a 
serious health risk. 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 
final 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 levels of risk.
    In December 1997, FDA advised manufacturers that the tracking 
requirements imposed by existing FDA regulations would remain in effect 
until the agency notified a firm of any change in responsibilities. On 
February 11, 1998, FDA sent 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. FDA issued tracking orders to four 
manufacturers of two additional devices known to be associated with 
serious risks, i.e., dura mater implants and AAA stent grafts. In 
September 1999, FDA limited the scope of tracking orders for two other 
device types, i. e., replacement heart valves and electromechanical 
infusion pumps. No additional types of devices have been added to the 
list of tracked devices during 2000. However, in August and October 
2000, FDA issued orders to three manufacturers without previous 
tracking systems in place, to begin tracking their own versions of 
devices already on the list of tracked devices, namely, replacement 
heart valves, continuous ventilators, and TMJ prostheses. The 
discussion below estimates the cost consequences attributable to these 
changes in the number of manufacturers tracking

[[Page 5949]]

devices and 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 $1.8 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 by 
limiting the scope of another order to devices that operate 
electromechanically and are 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 rule. The FDAMA-related changes to the 1993 list of tracked 
devices result in net savings to industry of approximately $17.4 
million per year (i.e., $19.2 million minus $1.8 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 final rule would also reduce agency costs by bypassing 
rulemaking procedures each time a device is added to or removed from 
the tracking list. This analysis does not quantify these costs, 
although substantial savings are expected from this more flexible and 
efficient system.
    FDA has reviewed this final 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 
final rule total less than $100 million in any one year, the final rule 
is not a ``significant regulatory action'' under the Executive order 
and FDA is not required to perform a cost benefit analysis under to the 
Unfunded Mandates Reform Act.
    These changes have, so far, resulted in net savings to industry. 
However, under the total annual distribution scheme used by FDA to 
estimate tracking costs by manufacturers, additional costs will be 
incurred by manufacturers that did not previously have tracking systems 
in place, as follows: (1) Four manufacturers of dura mater implants and 
AAA stents, which were not previously tracked under SMDA provisions but 
which are now subject to tracking orders issued by FDA, under FDAMA, in 
December 1998 and December 1999; and (2) three manufacturers of 
replacement heart valves, continuous ventilators, and TMJ prostheses 
which were ordered to be tracked in August and October 2000. To 
implement tracking systems, these seven manufacturers would incur total 
average annualized costs of approximately $1,718,500.00, or 
approximately $245,500 per manufacturer.
    According to the Department of Commerce, there are 873 
establishments with fewer than 500 employees manufacturing medical and 
surgical equipment and they account for about $2.4 billion in 
shipments, or about $2.7 million in shipments per establishment (Ref. 
1). Thus, $245,000 per manufacturer would be less than 1 percent of the 
average annual shipments of a small manufacturer of medical equipment.
    Under the total annual distribution scheme used by FDA to estimate 
distributor costs, additional costs would only be incurred by 
distributors when device types not previously tracked under SMDA 
provisions are added by FDA order, under FDAMA provisions, to the list 
of devices tracked by distributors. Implanted medical devices such as 
dura mater implants and AAA stents usually move directly from the 
manufacturer to the hospital,\1\ and therefore, the agency considers 
the hospital to be the final and only distributor in the distribution 
chain for implantable devices. FDA estimates that these hospital/
distributors will incur average annualized costs of $66,000 to track 
these two additional device types under FDAMA tracking provisions. 
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 final rule would not have a significant economic effect on a 
substantial number of small entities.
---------------------------------------------------------------------------

    \1\ ``From the Producer to Patient: Valuing the Medical Products 
Distribution Chain,'' Ernst & Whiney, 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. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the order and, consequently, a federalism 
summary impact statement is not required.

VIII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (the 
PRA) (44 U.S.C. 3501-3502). The title, description, and respondent 
description of the information collection provisions are shown 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.
    Title: Medical Devices; Device Tracking (Amended)
    Description: FDA is amending 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 final 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 rule also makes 
certain nonsubstantive revisions in the tracking regulation to remove 
outdated references or to simplify terminology.
    Under the revised scope of the amended tracking regulation, FDA is 
requiring manufacturers of class II or class III devices, including 
repackers, relabelers, and importers of these devices, when required by 
tracking orders issued by FDA for particular devices, to adopt a method 
of tracking the devices throughout distribution to

[[Page 5950]]

the device user or patient. Under patient confidentiality provisions, 
added to the amended regulation by this final rule, patients may 
refuse, or refuse permission, to release particular identification 
information. Though revisions of certain other requirements were made 
for simplification purposes, tracking requirements have not changed 
substantively.
    Manufacturers of tracked devices, i.e., devices subject to FDA 
tracking orders, continue to be required by the 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.
    As it was before revision by this final rule, the purpose of the 
tracking requirements is 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 received one public comment on the proposed rule of April 25, 
2000. On May 30, 2000, OMB approved the information collection related 
to the tracking of medical devices as it pertains to the previous rule 
approved in 1993. The approved information collection was assigned OMB 
control No. 0910-0442. At that time, OMB stated: ``OMB files comment on 
this collection as it pertains to the new proposed rule, and FDA will 
resubmit this collection with any changes along with the final rule. In 
drafting the final rule and paperwork submission, FDA should consider 
uses of appropriate technology (e.g. electronic submission of 
information) that could reduce burden.''
    With respect to OMB comment, FDA notes that the proposed rule, and 
now the final rule, provides for broad use of electronic submission for 
this information collection in accordance with FDA's regulations 
governing electronic submission of information (21 CFR part 11). FDA 
addresses the minor changes in the burden from the approved information 
collection below.
    FDA addresses the one public comment related to the tracking of 
infusion pumps earlier in this preamble. The comment objected to the 
issuance of tracking orders for a category of infusion pumps that FDA 
issued before the proposed rule. As explained above, FDA considers this 
comment beyond the scope of this rule.

                           Table 1.--Estimated Average Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                             No. of       Annual Frequency      Total Annual        Hours per
    21 CFR Section         Respondents       of Response         Responses          Response       Total Hours
----------------------------------------------------------------------------------------------------------------
821.2 (also 821.30(e))           4                 1                    4             12                48
821.25(a)                        1                 1                    1             76                76
821.25(d)                       19                 1                    9              2                38
821.30(a) and (b)           17,000                65            1,105,000              0.1666      184,093
821.30(c)(2)                     1                 1                    1             28                28
821.30(d)                   17,000                13              221,000              0.1666       35,497
Total                                                                                              219,780
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                               Table 2.--Estimated Average Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        No. of        Annual Frequency      Total Annual
                 21 CFR Section                     Recordkeepers     of Recordkeeping        Records         Hours per Record         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
821.25(b)                                                 209             41,331            8,638,179               0.2899               2,504,208
821.25(c)                                                 209                  1                  209              25.49                  5,328\2\
821.25(c)(3)                                              209              1,007              210,463               0.2899                  61,013
Total                                                                                                                                    2,570,549
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.

    Under OMB control No. 0910-0442, OMB approved a burden of 
10,175,490 responses and 2,790,693 burden hours. At that time, there 
were 207 manufacturers tracking devices. In 2000, FDA ordered three 
manufacturers that did not previously track devices to track their 
devices cleared for marketing and FDA rescinded a previous tracking 
order issued to one firm. Therefore, 209 manufacturers currently track 
devices (207 previous + 3 additional - 1 rescinded). FDA has no reason 
to believe that the change in the number of manufacturers will result 
in a change in the number of devices implanted. The change will only 
result in differences in market share.
    The PRA analysis stated in the April 2000 proposed rule remains the 
same except for the analysis of Sec. 821.25(c). Accordingly, the 
analysis stated in the proposed rule in 65 FR 24144 at 24150 for all 
sections of the final rule, other than Sec. 821.25(c) is incorporated 
herein.
    The analysis for Sec. 821.25(c) changes because of the additional 
manufacturers that received tracking orders since the publication of 
the April 2000 proposal. As described above, three additional 
manufacturers received orders, and one was rescinded, therefore the 
analysis of Sec. 821.25(c) is changed by the additional manufacturers.
    Under Sec. 821.25(c), manufacturers must establish standard 
operating procedures (SOPs) for collecting, maintaining, and auditing 
tracking data. FDA estimates the three new firms would take an average 
of 2 staff months to plan and develop a tracking system, and 1 month to 
draft and implement

[[Page 5951]]

SOPs, including the development of audit SOPs. 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 206 manufacturers that have had 
tracking systems in place. Manufacturers with tracking systems in place 
would review and/or revise their tracking system SOPs on an annual 
basis, expending approximately 10 percent of the amount of time spent 
originally in drafting the SOPs (18 hours). Over the next 3 years, 617 
firms would annually revise tracking SOPs as follows: 206 firms 
(excludes dura mater firms) for the first year, and 209 firms (includes 
3 new firms) for the second and third year. The total annual burden for 
revising SOPs for 3 years would amount to: 624 firms x 18 hours per 
firm = 11,232 hours. The annual burden would be 3,744 hours (11,232/3). 
Thus, the total burden for Sec. 821.25(c) would be 5,328 hours (1,584 
hours + 3,744 hours).
    The information collection provisions of the final rule have been 
submitted to OMB for review.
    Prior to the effective date of this final rule, FDA will publish in 
the Federal Register a notice announcing OMB's decision to approve, 
modify, or disapprove the information provisions in this final rule. An 
agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number.

IX. Reference

    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, 21 CFR part 
821 is amended 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 require a manufacturer to adopt a 
method of tracking a class II or class III device, if the device meets 
one of the following three criteria and FDA issues an order to the 
manufacturer: the failure of the device would be reasonably likely to 
have serious adverse health consequences; or the device is intended to 
be implanted in the human body for more than 1 year; or the device is a 
life-sustaining or life-supporting device used outside a device user 
facility. A device that meets one of these criteria and is the subject 
of an FDA order must comply with this part and is referred to, in this 
part, 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 the patient 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 abrogated 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, e.g., 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 a device that is intended and used 
only for temporary purposes or that is intended for explantation in 1 
year or less.
* * * * *
    5. Section 821.20 is revised to read as follows:


Sec. 821.20  Devices subject to tracking.

    (a) A manufacturer of any class II or class III device that fits 
within one of the three criteria within Sec. 821.1(a) must track that 
device in accordance with this part, if FDA issues a tracking order to 
that manufacturer.
    (b) When responding to premarket notification submissions and 
remarket approval applications, FDA will notify the sponsor by issuing 
an 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, the sponsor 
must track the device.
    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:
* * * * *

[[Page 5952]]

    (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 (c)(1)(ii) by removing the semicolon at the end of each paragraph 
and by 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 a new 
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: August 23, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-3076 Filed 2-7-02; 8:45 am]
BILLING CODE 4160-01-S