[Federal Register Volume 65, Number 168 (Tuesday, August 29, 2000)]
[Proposed Rules]
[Pages 52376-52391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21827]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 822

[Docket No. 00N-1367]


Postmarket Surveillance

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
implement the postmarket surveillance (PS) provisions of the Federal 
Food, Drug, and Cosmetic Act (the act), as amended by the FDA 
Modernization Act of 1997 (FDAMA). The purpose of this proposed rule is 
to provide for the collection of useful data or other information 
necessary to protect the public health and to provide safety and 
effectiveness information about devices.

DATES: Submit written comments on the proposed rule by November 27, 
2000. See section III of this document for the proposed effective date 
of a final rule based on this document. Submit written comments 
regarding the information collection by September 28, 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 electronic comments and 
other data to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. For other information about filing comments 
electronically, see the SUPPLEMENTARY INFORMATION section for 
information on electronic access and filing address. Submit written 
comments on the information collection to the Office of Information and 
Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., 
rm. 10235, Washington,

[[Page 52377]]

DC 20503, Attn: Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: David L. Daly, Center for Devices and 
Radiological Health (HFZ-510), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-3060.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What Is the Background of This Rulemaking?
    A. Legislative History
    B. Legal Authority
II. What Are the Contents of this Proposed Rule?
    A. Organization and Format
    B. General
    C. Notification
    D. Postmarket Surveillance Plan
    E. FDA Review and Action
    F. Responsibilities of Manufacturers
    G. Waivers and Exemptions
    H. Records and Reports
III. When Will the Regulation be Effective?
IV. What Is the Environmental Impact of This Regulation?
V. What Is the Economic Impact of This Regulation?
    A. Introduction
    B. Objectives of the Proposed Rule
    C. Risk Assessment/Baseline Conditions
    D. Cost of Postmarket Surveillance
    E. Design Costs
    F. Costs of Data Collection
      1. Costs for Primary Data Collection
      2. Costs for Secondary Data Collection
      3. Costs of Conducting Literature Searches
    G. Costs of Data Analysis, Reporting, and Recordkeeping
    H. Total Industry Costs of Postmarket Surveillance
    I. Costs to FDA for Oversight and Review
    J. Total Annual Costs of Postmarket Surveillance
    K. Benefits of the Proposed Rule
    L. Chronology of Historical Event
    M. Postmarket Surveillance and Risk Reduction
    N. Value of Avoided Mortality
    O. Frequency of Adverse Events
    P. Annual Benefits of the Proposed Rule
    Q. Annual Costs and Benefits of the Proposed Rule
    R. Small Business Analysis/Initial Regulatory Flexibility 
Analysis
    S. Description of Impact
    T. Analysis of Alternatives
    U. Ensuring Small Entity Participation in Rulemaking
VI. Conclusions
VII. How Can I Comment on This Proposed Rule?
    A. Electronic Access and Filing Address
    B. Written Comments
VIII. How Does This Regulation Comply With the Paperwork Reduction 
Act of 1995?

I. What Is the Background of This Rulemaking?

    The act (21 U.S.C. 301 et seq.) was amended by the Medical Device 
Amendments of 1976 (Public Law 94-295) to give FDA broad authority over 
medical devices. Other laws affecting FDA's device authority under the 
act include the Safe Medical Devices Act of 1990 (the SMDA) (Public Law 
101-629), the Medical Device Amendments of 1992 (MDA) (Public Law 102-
300), and FDAMA (Public Law 105-115). The SMDA established a new 
provision, section 522 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360l), which was later modified by the MDA and FDAMA. 
This section gives FDA the authority to require manufacturers of 
certain medical devices to conduct postmarket surveillance. This 
surveillance allows for identification of potential problems with 
medical devices by collecting useful data that can reveal unforeseen 
adverse events or other information necessary to protect the public 
health.
    FDA's decision to approve or clear a particular device is 
ordinarily based on limited premarket data. Even when there are 
premarket clinical studies, those studies typically can detect only 
those adverse events that are relatively frequent. PS studies can allow 
FDA and manufacturers to identify less common, but potentially life-
threatening, device problems that were not evident during premarket 
development, or were noted as a potential concern that did not warrant 
keeping the product from reaching the market. PS establishes a way to 
evaluate such relatively rare events and to identify actions that may 
minimize patient risk, such as training, labeling, or design 
modification.
    The act provides that FDA may require a manufacturer to conduct PS 
of a class II or class III device if: (1) Failure of the device would 
be reasonably likely to have serious adverse health consequences, (2) 
the device is intended to be implanted in the human body for more than 
1 year, or (3) the device is intended to be life-sustaining or life-
supporting and is used outside a device user facility.

A. Legislative History

    Congress first granted FDA the authority to require that 
manufacturers of certain medical devices conduct PS with the enactment 
of the SMDA. They later modified this authority in FDAMA, allowing the 
agency more discretion in imposing PS and establishing a time limit for 
prospective surveillance, but leaving intact the basic authority.
    The legislative history of the SMDA makes clear that the authority 
granted FDA under section 522 of the act to require PS of certain 
devices is a flexible authority that is intended to enable the agency 
to order manufacturers to collect data about unforeseen adverse events 
and other information to protect the public health. See, e.g., section 
522(a) of the act (listing types of devices covered by the 
requirement); H. Rept. 808, 101st Cong., 2d sess., p. 32, 1990; S. 
Rept. 513, 101st Cong., 2d sess., p. 42, 1990.
    Many problems or risks that may occur after a device is marketed 
cannot be detected before the device enters commerce. For a substantial 
majority of devices, FDA sees no clinical data before the device is 
commercially distributed. Section 522 of the act allows for monitoring 
of the earliest experience with a device once it is distributed in the 
general population under actual use conditions. In discussing the 
requirements in section 522 of the act, the House Report states that 
``premarket approval cannot detect all possible problems which may 
occur after a device is marketed. The Committee, therefore, expects 
that implants and other devices critical to human health will be 
subject to postmarket surveillance for some appropriate period of time 
after they are first marketed.'' (H. Rept. 808, 101st Cong., 2d sess., 
p. 32, 1990).
    The legislative history of the SMDA also notes weaknesses in other 
PS mechanisms. During passage of the SMDA, the U.S. Senate observed 
that the General Accounting Office (GAO) and the Office of Technology 
Assessment had found that reporting to FDA of potentially serious 
device hazards was incomplete and untimely for certain device-related 
injuries and malfunctions, despite FDA's mandatory medical device 
reporting (MDR) system. This finding was confirmed during congressional 
hearings. (S. Rept. 513, 101st Cong. 2d sess., p. 15, 1990.)
    Although reports of device-related problems increased following the 
issuance of the MDR regulation (49 FR 36325, September 14, 1984), GAO 
found apparent under-reporting of device-related reportable events and 
that many firms subject to the regulation were unaware of their 
obligation to report device-related deaths, serious injuries, and 
malfunctions to FDA. GAO reported that the more serious the event, the 
less likely it was to be reported. GAO found that only 50 percent of 
class I recalls, the recall classification associated with device-
related serious adverse health consequences or death, were preceded by 
MDR's. (PEMD-89-10, February 1989.)
    In addition to the under-reporting of device-related reportable 
events by manufacturers, GAO concluded that problems existed with the 
timely receipt of information. For example, information from 
legislative hearings

[[Page 52378]]

and elsewhere shows that the manufacturer of the Bjork-Shiley 60-degree 
Convexo-Concave heart valve had knowledge of unexpected device failures 
and deficiencies in its manufacturing process. FDA did not receive 
timely information necessary to initiate regulatory actions promptly to 
protect the public or to inform those persons implanted with the heart 
valve of what measures should be taken to minimize their risk.
    GAO also documented significant weaknesses in FDA's information 
gathering ability and its followup mechanisms, once information is 
received. The legislative history indicated a concern that FDA had not 
used its postmarket device authorities under section 518 of the act (21 
U.S.C. 360h). These authorities empower the agency to order a 
notification to persons subject to a risk, and to order repair or 
replacement of, or reimbursement for devices. Congress attributed the 
agency's failure to use its authority under section 518 of the act to 
the agency's reluctance to assert this authority and to a weak 
information base that did not support aggressive regulatory action.
    To address these concerns, the SMDA added a number of very 
important postmarket authorities to FDA's existing MDR authority, 
including authority to require PS for certain types of devices. In 
addition, the SMDA required the device industry to notify FDA of 
certain corrective actions, to track certain devices from the place of 
manufacture through the distribution chain and to the ultimate 
consumer, to cease distribution of a device and to notify users to 
cease use of the device, and to certify the number of MDR reports 
submitted.
    In practice, the provision for mandatory surveillance contained in 
the SMDA was so broadly worded that it caused uncertainty about the 
identity of devices subject to the requirement. There was also concern 
that the provision for mandatory surveillance could authorize studies 
of indeterminate duration for devices. To address these concerns, FDAMA 
amended section 522 of the act to repeal mandatory surveillance, to set 
a presumptive limit of 3 years on studies, and to provide FDA with 
broad discretion to implement PS on a case-by-case basis.

B. Legal Authority

    Section 522 of the act gives the agency authority to require PS of 
certain devices. Other provisions of the act empower FDA to implement 
the agency's PS authority and to monitor and enforce compliance with 
section 522 of the act.
    Section 502(t)(3) of the act (21 U.S.C. 352(t)(3)) provides that 
noncompliance with requirements imposed under section 522 of the act 
will result in the misbranding of the device that was subject to PS. 
Section 301 of the act (21 U.S.C. 331) makes several actions involving 
misbranded devices prohibited acts, and section 301(q) specifies that 
noncompliance with PS and submission of false reports related to PS are 
prohibited acts. FDA may initiate seizure of a misbranded device under 
section 304 of the act (21 U.S.C. 334), and may seek injunctive, 
criminal, and civil relief under sections 302 and 303 of the act (21 
U.S.C. 332 and 333) against individuals who commit prohibited acts.
    Section 519(a) of the act (21 U.S.C. 360i(a)) gives FDA authority 
to issue reporting and recordkeeping requirements necessary to show a 
product is not misbranded. The agency is proposing to require reports 
and records to demonstrate that devices subject to surveillance orders 
comply with them and are not misbranded under 502(t) of the act.
    FDA's general authority to inspect entities subject to section 522 
of the act orders comes from section 704(a) of the act (21 U.S.C. 
374(a)). Section 704(e) of the act authorizes the agency to inspect 
records required under section 519(a) of the act, including PS records 
that would be required by a final rule based on this proposed rule.

II. What Are the Contents of This Proposed Rule?

A. Organization and Format

    The Presidential Memorandum on Plain Language issued on June 1, 
1998, directed the agency to ensure that all of its documents are clear 
and easy to read. Part of achieving that goal involves having readers 
of a regulation feel that it is speaking directly to them. Therefore, 
the agency has attempted to incorporate plain language concepts through 
the use of pronouns and other plain language in this proposed rule as 
much as possible.
    We have also organized this proposed rule to make information 
easier to find by grouping related sections within subparts and placing 
them under unnumbered, centered headings. Section headings are phrased 
as questions that readers, especially anyone subject to a PS order, 
might ask, and we have incorporated first-person personal pronouns into 
these headings. For example, the heading of proposed Sec. 822.14 is, 
``May I reference information previously submitted instead of 
submitting it again?'' The text of each section contains the answer to 
the question posed in the heading. Frequently, the answer is stated in 
terms of what ``you'' (the reader) must do. For example, the answer to 
``May I reference information previously submitted instead of 
submitting it again?'' is, ``Yes, you may reference information that 
you have submitted in premarket submissions as well as other postmarket 
surveillance submissions. You must specify the information to be 
incorporated and the document number and pages where the information is 
located.''
    We have tried to make each section of the proposed rule easy to 
understand by using clear and simple language rather than jargon, 
keeping sentences short, and using active voice rather than passive 
voice whenever possible. We would like your comments on how effectively 
we have used plain language, the organization and format of the 
proposed rule, and whether these have made the document clear and easy 
to read.

B. General

    We are proposing this regulation to implement section 522 of the 
act, as amended by FDAMA. If a manufacturer fails to comply with 
requirements that FDA orders under section 522 of the act and this 
regulation, the device subject to the order is misbranded. In addition, 
the manufacturer would be committing a prohibited act under section 
301(q)(1)(C) of the act by failing to comply with PS requirements.
    The proposed regulation is intended to ensure that useful data or 
other information will be collected to address public health issues or 
questions related to the safety or effectiveness of devices for which 
the agency has issued PS orders. These issues or questions may include, 
among other things, the identification of unanticipated adverse events. 
They also may include the rate of known adverse events as the 
indications or conditions for use of the device change, e.g., from 
professional to over the counter use. We believe that the manufacturer 
is most likely to collect useful information through clear 
identification of the surveillance question(s) or issue(s) and a PS 
plan designed to address the question(s) or issue(s).
    We have defined the following terms in Sec. 822.3 of this proposed 
rule: Act, designated person, device failure, general plan guidance, 
investigator, life-supporting or life-sustaining device used outside a 
device user facility, manufacturer, postmarket surveillance,

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prospective surveillance, serious adverse health consequences, specific 
guidance, surveillance question, and unforeseen adverse event.
    Proposed Sec. 822.4 states that the regulation applies to any 
manufacturer that has been ordered to conduct PS by the agency, and 
identifies the statutory criteria that must be met before we may order 
PS.

C. Notification

    Section 522(a) of the act provides criteria a device must meet 
before we can impose PS. We may order PS of any class II or class III 
device if: (1) The failure of the device would be reasonably likely to 
have adverse health consequences, (2) the device is intended to be 
implanted for more than 1 year, or (3) the device is intended to be 
life-sustaining/life-supporting and is used outside a device user 
facility. This provision applies to all such devices, including devices 
that we review under the act, and devices (such as licensed in vitro 
diagnostic products) that we review under the licensing provisions of 
section 351 of the Public Health Service Act. In addition to the 
statutory criteria, we have developed additional discretionary criteria 
to determine when PS under section 522 of the act is an appropriate 
mechanism for addressing a PS question or issue. We have discussed 
these criteria in ``Guidance on Criteria and Approaches for Postmarket 
Surveillance'' (www//fda.gov/cdrh/modact/critappr.pdf). Because we will 
make determinations about PS on a case-by-case basis, we will notify a 
manufacturer in writing of the requirement to conduct PS (proposed 
Sec. 822.5) as soon as we make the determination (proposed Sec. 822.6). 
This may be during the review of the marketing application for the 
device, as the device goes to market, or after the device has been 
marketed for some period of time. This notification is referred to as 
the surveillance ``order'' and will specify the device(s) subject to 
the surveillance order, the reason that we are requiring PS, and any 
general or specific guidance that is available. We have identified the 
mechanisms available to appeal our decision to order PS of a particular 
medical device (proposed Sec. 822.7).
    We recognize that a manufacturer may have difficulty designing and 
submitting a PS plan to FDA within the statutory timeframe of 30 days 
from receipt of a surveillance order. We may, therefore, request a 
meeting with the affected manufacturer(s) to discuss the surveillance 
question and the possible approaches for the surveillance. We 
anticipate that this would generally occur prior to issuing a 
surveillance order for a particular device for the first time, and 
would be less likely to occur for subsequent orders for the same or 
similar devices. We may also request information from or meetings with 
manufacturers to determine whether a surveillance order is appropriate 
and necessary.

D. Postmarket Surveillance Plan

    By law, the manufacturer must submit a plan to conduct PS within 30 
days of receipt of notification of the requirement to conduct PS (the 
order). The manufacturer would be required to submit the original and 
two copies of the plan (proposed Sec. 822.8). Under the proposed rule, 
foreign manufacturers will be subject to the same reporting 
requirements as domestic manufacturers. We believe that the inclusion 
of foreign manufacturers will provide information that is needed to 
ensure the safety of medical devices. Domestic manufacturers marketing 
a device for export only are also subject to the provisions of section 
522(a) of the act because they are introducing the device into 
interstate commerce under the terms of the act.
    We have identified the contents of the submission in proposed 
Sec. 822.9, and the issues to be addressed in the design of the PS plan 
in proposed Sec. 822.11. It is essential that the manufacturer design 
the plan to address the specific PS question we have identified in the 
order. We will include guidance to manufacturers regarding the content, 
preparation, and submission of PS plans in the surveillance order.
    The plan must clearly describe the content and timing of interim 
and final reports. Each plan must outline reporting objectives, the 
rationale for each objective, a description of information to be 
reported, a description of reporting mechanisms, and proposed 
timeframe(s) (proposed Sec. 822.10).
    The statute requires that we determine that the person designated 
to conduct the surveillance has appropriate qualifications and 
experience. The qualifications and experience necessary will depend on 
the surveillance approach being used. For example, a person qualified 
to conduct a review and analysis of the literature and complaint files 
would not necessarily be qualified to conduct a prospective clinical 
study. Under proposed Sec. 822.9, the plan must clearly establish the 
qualifications and experience of the designated person responsible for 
conducting the proposed surveillance.
    Proposed Sec. 822.12 identifies guidance documents available to 
assist a manufacturer in the preparation of a submission or the design 
of a PS plan. ``Guidance on Criteria and Approaches for Postmarket 
Surveillance'' is also available through the Center for Devices and 
Radiological Health (CDRH) Facts-on-Demand system and on the Internet 
at the CDRH website at http://www.fda.gov/cdrh/modact/critappr.pdf.
    Proposed Sec. 822.14 describes the procedure for incorporating by 
reference information that the manufacturer has submitted in premarket 
or other postmarket submissions. For example, a manufacturer may 
reference the description of a device that he submitted as part of the 
premarket notification (510(k)) submission, or the PS plan that he 
submitted for another device. We believe referencing information will 
reduce duplicative reporting, thereby reducing the burden on both the 
manufacturer and FDA.
    Proposed Sec. 822.15 discusses the PS period. The statute limits 
the prospective surveillance period to 36 months, unless FDA and the 
manufacturer agree to a longer period. The surveillance period is the 
duration of actual surveillance, not the time elapsed since the 
issuance of the surveillance order. If we determine that a longer 
period of prospective surveillance is necessary and the manufacturer 
does not agree, FDA and the manufacturer may employ dispute resolution 
under section 562 of the act (21 U.S.C. 360bbb-1). We are in the 
process of issuing a guidance on using dispute resolution to resolve 
scientific disputes concerning the regulation of medical devices.
    In general, the regulations governing protection of human subjects 
(21 CFR part 50) and institutional review boards (IRB's) (21 CFR part 
56) apply to studies of unapproved and approved products regulated by 
FDA. This may include PS studies, depending on the approach used. There 
are some approaches to PS, such as the review of published literature, 
where the informed consent and IRB regulations would not be applicable. 
For other types of studies, for example, prospective studies, the 
patient should be provided with the basic elements of informed consent, 
including the extent to which records would be kept confidential. 
Therefore, a manufacturer should consider the need for IRB approval and 
informed consent when designing a surveillance plan.
    The above discussion regarding informed consent and IRB approval is 
not intended to preempt any State or local requirement to obtain 
informed consent or IRB approval. In addition, individual institutions 
may have requirements for informed consent and

[[Page 52380]]

IRB approval that apply to all researchers.
    FDA does not require, nor do we generally expect, PS to result in 
the collection of personal identifiers. In any PS study, we expect 
manufacturers to ensure that the surveillance approach they use 
incorporates whatever measures are appropriate to protect patient 
privacy. Some approaches to PS, such as the review of published 
literature, would not require the manufacturer to take any specific 
steps to protect patient privacy. Moreover, many existing data bases 
and registries either do not capture individual identifying data or 
restrict access to any information that would identify an individual 
patient. It is unlikely, therefore, that personal identifiers will be 
associated with study information.
    In some cases, however, we may determine that a particular PS plan 
requires the sponsor to take special measures to protect patient 
privacy. A PS plan that includes collection of personal information in 
identifiable form should include procedures that minimize any 
likelihood that patient identifiers will be transferred from the health 
care provider to the sponsor or any other third party except for 
purposes of the surveillance activity, and then only under conditions 
ensuring that it will be used for no other purpose.
    We invite comments on the issue of informed consent for PS.

E. FDA Review and Action

    In proposed Sec. 822.16, we describe the FDA review process for PS 
submissions. We will first determine that the submission is 
administratively complete, i.e., that the manufacturer has addressed 
all of the elements in proposed Sec. 822.9. We will then evaluate 
whether the surveillance plan is likely to result in the collection of 
data that will answer the surveillance question. We will evaluate the 
plan for scientific soundness, feasibility, and appropriateness to 
address the surveillance question. We will then evaluate the 
qualifications and experience of the person the manufacturer has 
designated to conduct the surveillance.
    Section 522(b) of the act requires that we review PS plan 
submissions within 60 days of receipt (proposed Sec. 822.17). We will 
notify the manufacturer in writing of the result of our review and 
identify any actions the manufacturer must take (proposed Sec. 822.18). 
Proposed Sec. 822.19 is a table that identifies the kinds of decisions 
that we may make, based on the adequacy of the PS plan, and the action 
that a manufacturer must take as a result of our decision. For example, 
if we send a manufacturer a letter stating that specific revisions or 
information must be submitted before we can approve the plan (an 
``approvable'' letter), the manufacturer must address the concerns in 
the letter and submit a revised plan within the specified timeframe. We 
intend to use an interactive review process whenever feasible, so some 
revisions may be requested, made, and submitted before a final decision 
letter is issued.
    Proposed Sec. 822.20 describes the consequences of failure to 
submit a PS plan, failure to conduct surveillance in accordance with an 
approved plan, or failure to submit a revised plan after we disapprove 
a plan. Each of these failures is a failure to comply with section 522 
of the act. As discussed in section I.B of this document, the failure 
to comply with section 522 of the act is prohibited under section 
301(q) of the act. This would also mean that the device is misbranded 
under section 502(t)(3) of the act.
    Any proposed modifications or changes in an ongoing study by the 
manufacturer must be submitted in writing for FDA approval prior to 
execution. For example, if there is a change in the designated person, 
the manufacturer must submit information regarding the qualifications 
and experience of the proposed replacement. Periods of PS under a 
protocol with unapproved changes may invalidate the study. Final 
authorization of any change rests with the agency (proposed 
Sec. 822.21).
    Proposed Sec. 822.22 discusses the procedures to be followed if FDA 
and the manufacturer do not agree about the content of the plan or if 
we disapprove the plan. We anticipate that most disagreements will be 
resolved through a meeting with the Director of the Office of 
Surveillance and Biometrics, CDRH. If there are still areas of 
disagreement about the content of the plan, a manufacturer may use the 
dispute resolution process (see discussion under proposed Sec. 822.15 
above) or request a hearing under 21 CFR part 16.
    Proposed Sec. 822.23 discusses the confidentiality of the plan. 
Until the plan is approved, FDA considers the contents of the 
submission confidential. Once we approve the plan, the contents of the 
original submission, amendments, supplements, and reports are 
disclosable in accordance with the Freedom of Information Act. We will 
continue to protect the confidentiality of trade secret or commercial 
confidential information, and information identifying individual 
patients.

F. Responsibilities of Manufacturers

    Manufacturers subject to this proposed rule must submit a plan to 
conduct PS within 30 days of receipt of the surveillance order 
(proposed Sec. 822.24). Once the plan has been approved, the 
manufacturer must conduct the surveillance in accordance with the 
approved plan (proposed Sec. 822.25). This means that the manufacturer 
must ensure that he initiates PS in a timely manner, conducts the 
surveillance in a scientifically sound manner, collects the data 
identified in the plan, and submits required reports in a timely 
manner. The surveillance plan and the approval order will identify 
timeframes for initiation of the surveillance and submission of 
reports.
    Any change of ownership of the device results in a change of 
responsibility for the corresponding surveillance plan, and does not 
terminate it (proposed Sec. 822.26). This applies whether the company, 
as a whole, changes ownership, or if only the rights to manufacture and 
sell the device change hands. The proposed rule contains one exception 
to this requirement. A manufacturer subject to this rule that is going 
out of business, permanently and completely, must notify FDA and 
discuss plans to complete or terminate PS and identify where and by 
whom the records will be retained (proposed Sec. 822.27). This 
exception would not apply if a manufacturer ceases distribution of a 
device subject to PS but still continues to do any other business; 
under those circumstances, the manufacturer must continue to fulfill 
the PS requirements (proposed Sec. 822.28).

G. Waivers and Exemptions

    We recognize that there may be some circumstances where a specific 
requirement of this regulation may not apply or may not be feasible, 
given the surveillance question and the design of the PS plan. 
Therefore, we will consider a request for a waiver of any specific 
requirement of this regulation. The manufacturer may submit this 
request as part of the PS plan submission or separately but must 
include information supporting the request (proposed Sec. 822.29).
    We will consider a request for exemption from the requirement to 
conduct PS for a manufacturer's device or a specific model of the 
device. The request must explain why we should exempt the device or 
specific model from PS and demonstrate why the surveillance question 
does not apply (e.g., the device does not have the

[[Page 52381]]

characteristic or feature that has raised the surveillance question) or 
does not need to be answered. Requests for exemption should not be used 
to request reconsideration of our determination that PS is necessary to 
address a public health or safety and effectiveness issue; a 
manufacturer may not submit a request for a waiver or exemption in lieu 
of the surveillance plan.

H. Records and Reports

    Proposed Secs. 822.31 and 822.32 specify the records to be 
maintained by the manufacturer and by the investigator. These records 
include correspondence between FDA and the manufacturer, the 
manufacturer and the investigator, and between investigators; signed 
investigator agreements; the approved PS plan; documentation of the 
date and reason for any deviation from the plan; all data collected and 
analyses conducted for PS; and any other records required by regulation 
or by order. The manufacturer must retain all records for a period of 2 
years after we have accepted the final report. Under some 
circumstances, we may require, by order, that the records be retained 
for a longer period of time (proposed Sec. 822.33).
    If there is a transfer of ownership or an investigator in the plan 
changes, the manufacturer must ensure that all records are transferred 
to the new manufacturer or investigator and that we are notified within 
10 days of the effective date of the change. The notification must 
include the name, address, and telephone number of the new manufacturer 
or investigator and certify that all records have been transferred on 
the specified date (proposed Sec. 822.34).
    We will review manufacturers' PS programs during inspections. In 
addition, persons with PS obligations other than manufacturers, e.g., 
clinical investigators, will be subject to periodic inspections. Any 
person authorized to grant access must permit authorized FDA employees, 
at reasonable times and in a reasonable manner, to enter and inspect 
any facilities where devices are held (including any establishment 
where devices are packed, held, used, or implanted, or where records of 
results from the use of devices are kept) (proposed Sec. 822.35).
    In general, we expect manufacturers to be able to produce records 
required under the proposed rule within 72 hours of the initiation of 
an inspection (proposed Sec. 822.36). This includes records and 
information required to be kept by this regulation that are in the 
possession of others under contract with the manufacturer to conduct 
the manufacturer's PS. We will state the reason or purpose for the 
request, and will identify to the fullest extent possible the 
information or type of information we are seeking. Proposed Sec. 822.37 
discusses our authority to inspect and copy records that identify 
subjects. Proposed Sec. 822.38 establishes that the manufacturer must 
submit interim and final reports in accordance with the approved PS 
plan. It also specifies that we may, in accordance with section 519(a) 
of the act, request information or reports that are not part of the 
plan when we believe that it is necessary for the protection of the 
public health and the implementation of the act. In any such request, 
we will identify the information to be provided, the reason for the 
request, and identify how we will use the information.

III. When Will the Regulation Be Effective?

    We are proposing that any final rule that may issue based on this 
proposed rule become effective 30 days after its date of publication in 
the Federal Register.

IV. What Is the Environmental Impact of This Regulation?

    We have determined under 21 CFR 25.30(h) that this action is of a 
class of actions 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.

V. What Is the Economic Impact of This Regulation?

A. Introduction

    We have examined the impact of the proposed rule under Executive 
Order 12866, 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 104-121)), and the Unfunded Mandates Reform Act of 
1995 (UMRA) (Public Law 104-4). Executive Order 12866 directs us to 
assess all costs and benefits of available regulatory alternatives, and 
when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). The Regulatory Flexibility Act requires us to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Section 202(a) of the UMRA requires that agencies 
prepare a written statement of anticipated costs and benefits before 
proposing any rule that may result in an expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100 million in any one year (adjusted annually for inflation).
    We believe that this proposed rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order. 
The proposed rule is not a significant regulatory action as defined by 
the Executive Order. Exercise of our PS authority could have a 
significant impact on a substantial number of small entities. We have 
included a preliminary regulatory flexibility analysis at the end of 
this section for comment. Finally, we have determined that the proposed 
rule is not a significant action as defined in the UMRA, and will not 
have an effect on the economy that exceeds $100 million in any one 
year.

B. Objectives of the Proposed Rule

    The objective of the proposed rule is to enhance the public health 
by reducing the incidence of medical device adverse experiences. The 
primary problem is that we currently lack data that may reveal 
unforeseen adverse events relevant to the safety and effectiveness of 
specific devices. The proposed rule will address this concern by 
implementing section 522 of the act, as amended by FDAMA, to require 
manufacturers of specific medical devices to conduct PS. We expect PS 
to identify uncommon, but potentially life-threatening, device-related 
outcomes that were not noted during premarket development, or were 
noted as a continuing concern but did not warrant withholding the 
device from the market.

C. Risk Assessment/Baseline Conditions

    In the absence of the proposed regulations, neither FDA nor device 
manufacturers will have complete confidence that uncommon and 
unforeseen events have been adequately identified for marketed devices. 
Currently, hundreds of medical devices are marketed each year for which 
failure could be reasonably likely to have serious adverse health 
consequences, or that are intended to be implanted in a human body for 
more than 1 year, or that are life-sustaining or life-supporting and 
used outside a device user facility. Devices with these characteristics 
range from implantable pacemaker pulse generators and vascular graft 
prostheses to dental and orthopedic implants.
    Our decision to approve or clear a particular device for marketing 
is based on a comparison of the expected health benefits of the device 
to the expected risk of adverse outcomes due to device

[[Page 52382]]

failure. Premarket clinical studies, however, are typically designed to 
detect only relatively frequent adverse events. As a result, we often 
base premarket approval decisions on risk/benefit relationships that 
include only relatively frequent risks. Given this lack of complete 
data, neither FDA nor device manufacturers can be confident about the 
likelihood of serious, but infrequent, adverse events. Such events can 
have drastic consequences on dozens, if not hundreds of patients when a 
device is marketed to thousands of patients. PS provides a mechanism 
for gaining an early awareness and better understanding of such rare 
events, thus preventing further unnecessary risk to patients. 
Surveillance may identify actions that minimize risks, such as 
training, labeling, design modification, or patient selection criteria. 
In extreme cases, surveillance may show that the subject device should 
be removed from the market.

D. Costs of Postmarket Surveillance

    A critical cost factor is the size of the expected surveillance. We 
have approved some surveillance protocols under SMDA, but rescinded 
most of these upon passage of FDAMA. While we cannot be precise, we 
estimate, based on a review of currently marketed devices, that an 
average of six generic device types, each with an average of five 
manufacturers, may be the subject of PS orders each year. This 
frequency would result in the initiation of 30 PS orders each year. 
Assuming that the duration of each PS is limited to 3 years, at any 
given time, 90 PS studies could be ongoing and subject to FDA review. 
An additional 30 PS plans would be in preliminary, design stages.
    The surveillance becomes larger and more extensive as the 
acceptable rate of adverse events becomes smaller. Statisticians 
explain that if one assumes a cumulative Poisson distribution, a 0.95 
probability of noting an adverse event with the incidence rate of (p) 
implies that the product of p and the number of observations (n) must 
approximately equal 3 (i.e., pn=3). For example, the surveillance must 
include about 30,000 observations to be 95 percent confident that a PS 
will detect events that occur at a frequency of 0.0001 (1 event out of 
10,000 observations). The PS designed to detect more frequent events 
requires fewer observations. The surveillance must include about 1,500 
observations to be 95 percent confident that PS will detect events that 
occur at a frequency of 0.002 (2 events out of 1,000 observations). We, 
along with device manufacturers, will need to take these considerations 
into account when designing PS plans.
    The manufacturer would generally complete the required PS within 36 
months, with at least semiannual observations. (PS utilizing literature 
searches may require monthly searches, although less frequent reviews 
may be appropriate at times.) These observations would be collected by 
either primary data collection from controlled clinical studies, 
secondary data collected from other data bases or sources (such as 
Medicare data bases, registries or tracking systems, and other types of 
studies), or published studies in the medical literature as 
supplemented by our current reporting systems. For purposes of this 
analysis, we estimate that 10 percent of the PS will require primary 
data collection, 50 percent may utilize secondary data sources, and 40 
percent may collect adequate data from published reports. Manufacturers 
will incur varying costs for both design and analysis/reporting/
recordkeeping phases of each surveillance in addition to the costs of 
data collection. In addition, we will incur costs to review the data 
submitted by manufacturers.

E. Design Costs

    We would expect the manufacturer of each device that is subject to 
a PS order to develop an analysis plan for implementing the data 
collection. We would review and approve this plan prior to initiation. 
The design of a PS utilizing primary data collection would require more 
resources than either secondary collection or literature searches. 
Senior industry regulatory staff would review and approve each type of 
PS, however, before submission to us. For this estimate, we have 
assumed that the design of PS utilizing primary data collection would 
require 3 weeks of industry staff time, PS utilizing secondary data 
sources would require 2 weeks of time, and PS utilizing published 
literature would require only 1 staff week. According to the U.S. 
Bureau of Labor Statistics (1997), in 1997 the median weekly rate of 
compensation for managerial and professional personnel in this industry 
group (SIC 3841) was approximately $1,300. We have assumed an 
additional cost of $700 per week to account for administrative and 
clerical resources for a total estimate of industry resources at $2,000 
per week. Therefore, the design of PS utilizing primary data collection 
would equal $6,000, PS utilizing secondary data collection would equal 
$4,000, and PS utilizing only a literature search would equal $2,000. 
These costs would occur prior to the first year of surveillance for 
each study.

F. Costs of Data Collection

1. Costs for Primary Data Collection
    Primary data collection utilizing clinical trials will generally be 
impractical because of difficulties obtaining patient and clinician 
participation. In addition, this type of data collection would have 
significant resource requirements. Primary data could, however, be used 
to survey smaller populations, or populations that could experience 
relatively high rates of adverse events. For this analysis, we have 
assumed that a rigorous PS plan might call for observing 300 subjects 
semiannually over a 3-year period. This plan would generate 1,800 total 
observations and might be confidently expected to identify adverse 
events that occur with a frequency of 0.002, or 2 per 1,000. Moreover, 
patient dropouts would occur and some observations would not result in 
usable data, raising the number of required subjects to perhaps 350. 
Physicians would examine patients and provide the results of these 
required observations directly to manufacturers.
    The costs of this data collection would be significant. While in 
most cases, we would not require additional procedures or tests for a 
patient, it is possible that some extra examinations would be required 
to ensure that the patient's device was still functional. In addition, 
normal physiologic data would likely be consistently recorded, 
submitted to the device manufacturers, and archived for further review. 
We have estimated that these data would require a direct cost of $150 
per observation for the physician or medical facility to collect the 
data and submit it in proper form to the sponsoring manufacturer. 
Therefore, the cost of collecting these data would equal $300 per 
patient per year, or $105,000 per year. The present value of the costs 
of collecting these primary data over a 3-year period (using a 7 
percent discount rate) is $276,000 per PS.
    In addition, the patient/subject is likely to incur opportunity 
costs associated with being part of PS clinical studies. Because the 
ultimate purpose of the PS is to continue marketing the device, the 
patient is likely to incur costs for procedures and tests that provide 
him or her no direct benefit. We have estimated that such trials may 
require approximately 1 hour of patient time (including travel). 
Assuming that the opportunity cost of patients is approximately $26 per 
hour, the annual cost to patients of lost opportunity for PS utilizing 
primary data is $18,200 per year. The present value of the costs of

[[Page 52383]]

3 years of data collection (at 7 percent discount rate) is $48,000.
    We, therefore, estimate the total present value of the costs for 
primary data collection to be $324,000 per PS study.
2. Costs for Secondary Data Collection
    The use of secondary data for PS would not be as costly as the use 
of primary data. Manufacturers may obtain secondary data sets from both 
public and private sources, depending on the nature of the proposed 
surveillance, and we estimate that these data would cost approximately 
$50,000 per year to obtain and maintain for each surveillance. These 
data would include sufficient observations to ensure that infrequent 
events would be identified, but the expected frequency level may vary 
by device and patient characteristics. The present value of the costs 
of using secondary data sources for PS (at a 7 percent discount rate 
for 3 years) is $131,000.
3. Costs of Conducting Literature Searches
    We believe that PS utilizing reviews of published literature and 
analyses of our current reporting system may require monthly 
collections, although less frequent reviews may be acceptable for some 
surveillances. As a rule, we assume that a professional employee would 
take approximately 3 days per month to assess published accounts and 
ensure that any useful data are considered. As stated earlier, the 
median weekly compensation rate for professional employees in this 
industry was approximately $1,300 in 1997. This implies that the cost 
of reviewing published literature would equal $780 per month for 
professional staff resources. Administrative and clerical support would 
likely add an additional $420 per month for a total cost of $1,200. 
Annual costs for conducting this type of PS would equal $14,400, and at 
a 7 percent discount rate, the present value of the costs of this data 
collection equals $38,000.

G. Costs of Data Analysis, Reporting, and Recordkeeping

    PS is likely to entail the preparation and submission of four 
reports during the course of all types of surveillance: An initial 
report at the outset, two annual interim reports, and a final report 
including data analysis. In addition, manufacturers will be required to 
keep data available for 2 years. We assume that this category of costs 
is likely to be equivalent for each type of PS.
    The initial and interim progress reports are expected to be 
relatively brief. We expect that each report would require only 1 
resource week of supported professional time to be completed for a cost 
of $2,000 per report. The final data analysis and report would be much 
more extensive, and could require up to 3 months of resources to 
complete (statistical, medical research, legal, and senior regulatory 
affairs staff would likely all have input to final reports). The 
estimated cost of preparing and submitting a final PS report is 
$26,000.
    We estimate that the total cost of maintaining records for 2 years 
after completion of the surveillance will equal $500 per year. The 
present value of these reporting/recordkeeping costs (at a 7 percent 
discount rate) equals $28,000 per surveillance.

H. Total Industry Costs of Postmarket Surveillance

    The annual cost to industry for the conduct of PS is the sum of the 
present value of the costs of the expected studies. Each PS requiring 
primary data collection has a present value cost of $358,000 ($6,000 
for design, $324,000 for data collection (including $48,000 of patient 
opportunity cost), and $28,000 for reports and recordkeeping). Each PS 
requiring secondary data collection has a present value cost of 
$163,000 ($4,000 for design, $131,000 for data collection, and $28,000 
for reports and recordkeeping). Each PS requiring literature searches 
has a present value cost of $68,000 ($2,000 for design, $38,000 for 
data collection, and $28,000 for reports and recordkeeping).
    We expect to issue 30 PS orders each year. We expect that 10 
percent (3 PS') of these will require primary data collection. The 
present value of the costs for these surveillances is $1.1 million. We 
expect that 50 percent (15 PS') of the 30 PS orders will use secondary 
data collection. The present value of the costs for these surveillances 
is $2.4 million. The remaining 40 percent of annual PS orders (12 PS') 
will use literature searches. The present value of the costs for these 
surveillances is $0.8 million. Since we expect to issue only 30 
surveillance orders each year, the annual cost to industry of this 
regulation is the sum of the present value costs, or $4.3 million.

I. Costs to FDA for Oversight and Review

    We expect that 120 reports will be submitted each year as a result 
of this regulation (30 initial reports, 60 interim progress reports, 
and 30 final data analyses). If each report, on average, required 2 
weeks of review time, we will need five review fulltime employees 
(FTE's) to oversee the program. We would require an additional 2.5 
FTE's in support and management resources. We have estimated that the 
cost of each FTE is approximately $117,300. Therefore, the annual cost 
to FDA of maintaining PS is estimated to equal $0.9 million per year.

J. Total Annual Costs of Postmarket Surveillance

    We estimate that the total annual cost for operating and 
maintaining a PS program is $5.2 million. Most of these costs ($4.3 
million) are direct costs to manufactures while $0.9 million are our 
costs of operating the program.

K. Benefits of the Proposed Rule

    The expected benefit of the proposed rule is the reduction in 
avoidable adverse events attributable to the earlier detection of 
potential problems. Possible outcomes of PS include withdrawal of the 
device from the market, changes in labeling, changes in user training, 
modification of the device design, or (most likely) assurance that the 
device does not pose an unreasonable risk to the public health. These 
benefits are not easily quantified because they would vary by device; 
but the greatest benefit would be realized when other regulatory 
safeguards, such as early warning through the MDR system or 
preproduction design controls, fail to detect and resolve serious 
problems. To illustrate the potential benefits of PS, we reviewed our 
historical records to identify and quantify the benefits of a major 
adverse event that could reasonably have been mitigated if this 
proposed rule had been in place.

L. Chronology of Historical Event

    A particular type of implanted heart valve was approved and quickly 
accepted for patient use in 1979 because of its ability to reduce the 
risk of blood clots in patients. The premarket decision to approve the 
device considered clinical data that included an observation of one 
failure. The device was marketed for 8 years and implanted a total of 
82,000 times. By 1999, there were 462 device failures and 300 resultant 
fatalities.
    During the first marketing year, 5,000 patients received the device 
and 2 devices failed. During the second year, an additional 11,000 
devices were implanted and 3 devices failed. During the third year, 
14,000 devices were implanted and 7 devices failed. At this point of 
marketing, a total of 30,000 devices had been implanted and 12 had 
failed. No failures were reported in

[[Page 52384]]

other similar devices marketed during this period.
    We believe that had PS been in effect at that time, we would have 
likely made this device subject to a PS order because of the noted 
premarket strut failure. In general, any failure to any heart valve 
would have been deemed serious, and potentially catastrophic. We would 
have been concerned about the occurrence of a strut failure during 
premarket testing. While this concern would not have delayed marketing 
approval, subsequent strut failures would have been sufficient to start 
the PS mechanism, if it had been available.
    A likely surveillance plan would have required the manufacturer to 
determine the frequency of strut failures and identify contributing 
causes. Such a plan would have likely detected problems with the device 
by the end of the third year; potentially avoiding a total of 52,000 
implants (82,000-30,000). Given the substantial number of patients 
implanted and the relatively low failure rate for the number of 
semiannual patient observations after 3 years (12102,000 = 
.0001), it is unlikely that the required PS would have involved the 
collection of primary data through prospective trials. Nevertheless, by 
analyzing their respective failure rates by using patient registries 
that would include all implanted devices, the manufacturer would have 
noted all complications and failures. Special attention would have been 
paid to all adverse events (both expected and unexpected), with special 
attention paid to strut fractures, early valve replacement, and deaths. 
Because all patients and all implants would have been entered into this 
registry, each occurrence of valve fracture would have been noted, and 
this information would have been used to determine the best course of 
action to protect the public health. In this case, it is likely that no 
valves would have been implanted in patients after the third year of 
marketing.

M. Postmarket Surveillance and Risk Reduction

    If PS prevented 63 percent of the actual implants 
(52,00082,000), then it is likely that about 63 percent of the 
device failures could also have been avoided. As of 1999, the device 
has failed 462 times. Consequently, if the device had been removed from 
the market after its third year, about 293 failures would have been 
avoided over an 18-year period (1981 to 1999). Moreover, the 65 percent 
fatality rate for failures implies that the 190 fatalities associated 
with these 293 failures would have been avoided.

N. Value of Avoided Mortality

    There are no precise methodologies for estimating the value of 
preventing human fatalities. Economists, however, have attempted to 
place a dollar value on the avoidance of fatal risks based on society's 
implicit willingness to pay to avoid such risks. Currently, the 
literature shows that $5 million may represent an approximate value of 
society's willingness to pay to avoid a statistical fatality. This 
value is reduced by an appropriate discount factor, however, to the 
extent that the averted fatalities would occur in future time periods.

O. Frequency of Adverse Events

    To develop a possible scenario of future benefits we have assumed 
that, once within the next 25 years, the rule would prevent an event 
with characteristics identical to the heart valve incident discussed 
above. We cannot predict the precise year of the expected future event, 
but based on the past pattern of device failures, if the proposed rule 
identified a device with the described failure characteristics in the 
first year after completion of the first surveillance group (actually 
the fourth year of implementation), the current present value dollar 
benefit (assuming a 7 percent interest rate) of the avoided fatalities 
would be $405.5 million. If PS identified a potential device failure 
during the 10th project year, the present value of the dollar benefits 
for that event would be $270.2 million. If the device failure were not 
identified until the 25th year, the present value of the monetized 
benefits would be $97.9 million. Because we assume that, in the absence 
of this rule, the device failure would occur only once during the next 
25 years, the likelihood of an initial failure in any 1 future year is 
only .04. Thus, we estimate the overall expected present value of 
avoiding such a future device failure at $192.0 million.
    However, PS is not expected to be infallible. We have estimated 
that typical PS design will provide a 95 percent confidence that 
infrequent adverse events will be identified. Therefore, we would 
expect to identify potential device failures such as described 95 
percent of the time. To account for this, the present value of avoiding 
future device failures attributable to this proposed regulation is 
expected to equal 95 percent of the total amount, or $182.4 million.

P. Annual Benefits of the Proposed Rule

    In the illustrative case described above, we have amortized 
society's willingness to pay to avoid these fatalities over the 
evaluation period. This is because the costs of PS are ongoing and 
would be expended each year whether a device failure occurred or not. 
The current net value of avoiding these fatalities ($182.4 million), 
when amortized over 25 years, using a 7 percent discount rate, will 
result in average annualized benefits of $15.7 million.

Q. Annual Costs and Benefits of the Proposed Rule

    We have estimated the annual costs of PS to equal $5.2 million. We 
estimated benefits based on the avoidance over the next 25 years of 
just one serious event to equal $15.7 million per year.

R. Small Business Analysis/Initial Regulatory Flexibility Analysis

    We believe that it is likely that the proposed rule will have a 
significant impact on a substantial number of small entities and have 
conducted an initial regulatory flexibility analysis. This analysis is 
intended to assess the impact of the rule on small entities and to 
alert any potentially impacted entities of the expected impact. We 
request that such entities review the proposed rule and submit comments 
to us.

S. Description of Impact

    The objective of the proposed rule is to reduce the number of 
adverse events associated with failure of medical devices by 
implementing section 522 of the act, as amended by FDAMA, to require PS 
of specific devices. This surveillance will be designed to identify, as 
early as possible, potentially dangerous but rare adverse device-
related events. Our statutory authority for the proposed rule is 
discussed earlier in this preamble.
    Makers of four categories of devices are likely to be affected by 
the proposed regulations: Diagnostic substances (SIC 2835), surgical 
and medical instruments (SIC 3841), dental equipment and supplies (SIC 
3843), and ophthalmic goods (SIC 3851). This proposed rule would affect 
manufacturers (regardless of size) of: (1) Devices for which failure 
would be reasonably likely to have severe health consequences, (2) 
devices to be implanted in a human body for more than 1 year, and (3) 
devices that are life-sustaining or life-supporting outside a device 
user facility, because PS will likely be required for some of their 
currently marketed and new devices.
    Manufacturers within these industry groups are typically small. 
Over 65 percent of the establishments in these 4 industries have 20 or 
fewer employees and the companies have an average of

[[Page 52385]]

1.09 establishments per company. Manufacturers in these industries are 
highly specialized, with between 83 and 98 percent of establishment 
sales within the affected industries. In addition, between 84 and 98 
percent of diagnostic, medical, dental, and ophthalmic products are 
supplied by establishments within these industries. The Small Business 
Administration classifies as small any entity with 500 or fewer 
employees for all 4 industries. There is a high likelihood that 
manufacturers of some of the devices that would be subject to this 
proposed rule will include small entities.
    The average company in these industries has about $9.8 million in 
annual revenues and about 72 employees. Based on the cost assumptions 
described above, any company conducting PS with primary data collection 
would expend 3.7 percent of annual revenues. Secondary data collection 
would cost an average company 1.7 percent of annual revenues. 
(Literature searches are not expected to impose significant costs). 
Because 60 percent of the expected PS orders would require significant 
outlays, we believe that a substantial number of small entities would 
be significantly affected.
    We specifically solicit comment on the issue of the impact of this 
proposed rule on small entities.

T. Analysis of Alternatives

    We examined and rejected the following alternatives to the proposed 
rule: (1) No action, (2) reliance on premarket approval application 
(PMA) annual reports, (3) increased use of PMA postapproval studies, 
(4) reliance on MDR reports, (5) increased educational effort to 
improve all reporting mechanisms, and (6) exemption of small 
manufacturers from PS requirements. We have rejected these alternatives 
at this time for the following reasons:
Alternative 1
    Other sources of postmarket data or information exist, including 
PMA annual reports and other mechanisms. However, these sources are not 
always adequate to address specific postmarket issues that arise for 
specific devices. The proposed rule describes a process that is 
intended to identify sources of information available to the agency and 
determine their ability to address the postmarket issue prior to 
issuing a PS order. We would be able to meet with the affected industry 
sector to determine what information is currently available and whether 
that information may be modified to answer specific public health 
questions. Reliance on the current sources of postmarket data would not 
efficiently meet the objective of reducing avoidable adverse events.
Alternative 2
    We considered increasing the requirements for data submission in 
PMA annual reports. This alternative was rejected because not all 
devices that meet the PS criteria are subject to PMA annual reports, 
and annual reports would not be specific enough to address issues for 
each type of device. In addition, the costs of requiring detailed data 
submissions for all affected devices would be extremely high. We 
rejected this alternative.
Alternative 3
    If we increased postapproval studies, the expected compliance costs 
would be much greater, since postapproval studies generally consist of 
primary data collection. If a postmarket issue is identifiable at the 
time of approval, postapproval studies could be designed to collect 
meaningful data. However, if an issue would arise after FDA approval, 
this mechanism would not be helpful in meeting the objectives of the 
proposed rule. In addition, because all class II devices are marketed 
through premarket notification procedures, postapproval studies are not 
an option. We rejected this alternative.
Alternative 4
    We rejected the alternative of relying on an enhanced MDR system. 
While MDR's are extremely important in assessing public health, it is a 
passive system of data collection that relies on reports from concerned 
professionals and manufacturers or their representatives who become 
aware of device problems. Often MDR reports are not specific enough to 
address discrete issues. We believe that the public health objectives 
are better met by requiring more active data collection and analysis by 
the responsible manufacturers of particular devices.
Alternative 5
    FDA did not select the alternative of increased education in lieu 
of PS because any educational effort would require that FDA have 
sufficient information. Surveillance would be ordered to collect 
information that might lead to educational efforts to correct any noted 
problem. Thus, FDA did not believe that education alone would reduce 
adverse events.
Alternative 6
    We rejected the alternative of exempting small device manufacturers 
from the proposed requirements. We recognize that surveillance would 
likely cause a significant impact on small entities. However, the vast 
majority of device manufacturers are small and any exemption would 
seriously reduce the effectiveness of the proposed rule. In addition, 
devices manufactured by small entities could as easily meet the 
criteria the law establishes and FDA uses to impose a PS order.
    We solicit comments on any other alternatives that meet the stated 
objective.

U. Ensuring Small Entity Participation in Rulemaking

    We believe it is possible that the proposed rule could have a 
significant impact on a substantial number of small entities. The 
impact would include the costs of conducting PS for specific devices. 
We solicit comments from affected entities to ensure this impact is 
analyzed.
    The proposed rule will be available on the Internet at http://www.fda.gov for review by all interested parties and comments 
considered. In addition, CDRH's Division of Small Manufacturers 
Assistance will distribute the proposed rule through its established 
procedures for information dissemination during the comment period to 
ensure there is wide notice of the proposed rule and to solicit 
comments from small businesses.

VI. Conclusions

    We have examined the impacts of the proposed rule implementing PS 
for specific medical devices. Based on these estimates, the average 
annual quantified benefits of $15.7 million exceed the average 
annualized costs of conducting surveillance ($5.2 million). These 
benefits assume that between three and four statistical fatalities will 
be avoided each year because of this proposed rule. We also expect 
additional benefits, not easily quantifiable, such as assurance that a 
marketed device does not pose an unreasonable risk to the public health 
and improvements in the design, labeling, and user training for 
devices.
    We have concluded that it is likely that this rule will have a 
significant economic impact on a substantial number of small entities.
    We solicit comment on all aspects of this analysis and all 
assumptions used.

VII. How Can I Comment on This Proposed Rule?

A. Electronic Access and Filing Address

    You may view an electronic version of this proposed rule on the 
Internet at http://www.fda.gov. You may also

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comment on the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Please include ``Attention: Docket 
No. 00N-1367'' and your name and return address in your Internet 
message. If you do not receive a confirmation from the system that we 
have received your Internet message, contact us directly at 301-827-
6880. FDA is working to set up a system that would allow commenters to 
view already submitted comments. When this system is available, we will 
publish a notice in the Federal Register.

B. Written Comments

    You may send written comments on this proposed rule electronically 
or by hard copy (see the ADDRESSES section).
    All comments on the proposed rule should be specific, confined to 
issues pertinent to the proposed rule, and should explain the reason 
for any recommended change. Where possible, you should reference the 
specific section or paragraph of the proposal that you are addressing. 
FDA may not consider or include in the administrative record for the 
final rule comments that we receive after the close of the comment 
period (see the DATES section) or comments delivered to an address 
other than that listed above (see the ADDRESSES section).

VIII. How Does This Regulation Comply With the Paperwork Reduction 
Act of 1995?

    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 (the PRA) (44 U.S.C. 3501-
3520). A description of these provisions is given below with an 
estimate of the annual reporting and recordkeeping burden. The estimate 
includes the time for reviewing instructions, searching existing data 
sources, gathering and maintaining the data needed, and completing and 
reviewing each collection of information.
    With respect to the following 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: Postmarket Surveillance
    Description: FDA is proposing to implement the PS provisions of 
section 522(a) of the act, as added to the act by the SMDA and amended 
by FDAMA. The purpose of these proposed changes is to provide for the 
collection of useful data and other information necessary to protect 
the public health and to provide safety and effectiveness information 
about the device after the device is marketed. This data or information 
would be different from and supplemental to information collected under 
other provisions, such as MDR.
    Description of Respondents: Manufacturers.
    FDA estimates the burden for this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
822.9 and 822.10                       30               1              30             120           3,600
822.21                                  7               1               7              40             280
822.27                                  1               1               1               8               8
822.28                                  3               1               3              40             120
822.29                                  5               1               5              40             200
822.30                                  1               1               1             120             120
822.34                                  5               1               5              20             100
822.38                                 90               2             180              80          14,400
Total                                                                                             18,828
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                Table 2.--Estimated Annual Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
----------------------------------------------------------------------------------------------------------------
822.31                                 90               1              90              20           1,800
822.32                                270               1             270              10           2,700
Total                                                                                              4,500
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA has had limited experience with PS under SMDA, and FDAMA 
significantly modified the provisions of section 522 of the act. We 
expect that at least some of the manufacturers will be able to satisfy 
the PS requirement using information or data they already have or are 
already collecting for other purposes. For purposes of calculating 
burden, however, we have assumed that each PS order can only be 
satisfied by a 3-year clinically-based surveillance plan, using three 
investigators. Based on current staffing and resources, we anticipate 
that we will identify surveillance issues for 6 generic devices each 
year. On average, 5 different manufacturers will market each of those 
devices, so we expect to issue 30 PS orders each year.
    Each manufacturer will be required to submit a PS plan (21 CFR 
822.8 and 822.10) within 30 days of the receipt of the order and 
interim and final reports on the progress of the surveillance (21 CFR 
822.38) during the course of the surveillance. After the third year of

[[Page 52387]]

implementation, 30 manufacturers will complete their surveillance each 
year. Therefore, by year three, we will have reached a steady state, 
with 90 manufacturers and 270 investigators in various stages of PS 
each year. We anticipate that we may occasionally ask for additional 
information, such as distribution numbers or patterns, on a case-by-
case basis. We anticipate that a small number of respondents will 
propose changes to their PS plans (21 CFR 822.21), request a waiver of 
a specific requirement of this regulation (21 CFR 822.29), or request 
exemption from the requirement to conduct PS of their device (21 CFR 
822.30). Our experience has shown that a few respondents will go out of 
business (21 CFR 822.27) or cease marketing the device subject to PS 
(21 CFR 822.28) each year. In addition, manufacturers must certify 
transfer of records if the sponsor or the investigator in the plan 
changes (21 CFR 822.34). We anticipate that this will apply to a small 
number of respondents.
    The regulations in 21 CFR 822.26 do not constitute information 
collection subject to review under the PRA because ``it entails no 
burden other than that necessary to identify the respondent, the date, 
the respondent's address, and the nature of the instrument'' (21 CFR 
1320.3(h)(1)).
    In compliance with section 3507(d) of the PRA, we have submitted 
the information collection requirements of this proposed rule to OMB 
for review. Interested persons are requested to send comments regarding 
information collection by September 28, 2000, to the Office of 
Information and Regulatory Affairs, OMB, New Executive Office Bldg., 
725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy Taylor, 
Desk Officer for FDA.

List of Subjects in 21 CFR Part 822

    Postmarket surveillance, 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, it is 
proposed that 21 CFR part 822 be added to read as follows:

PART 822--POSTMARKET SURVEILLANCE

Subpart A--General Provisions
Sec.
822.1  What does this part cover?
822.2  What is the purpose of this part?
822.3  How do you define the terms used in this part?
822.4  Does this part apply to me?
Subpart B--Notification
822.5  How will I know if I must conduct postmarket surveillance?
822.6  When will you notify me that I am required to conduct 
postmarket surveillance?
822.7  What should I do if I do not agree that postmarket 
surveillance is appropriate?
Subpart C--Postmarketing Surveillance Plan
822.8  When, where, and how must I submit my postmarket surveillance 
plan?
822.9  What must I include in my submission?
822.10  What must I include in my surveillance plan?
822.11  What should I consider when designing my plan to conduct 
postmarket surveillance?
822.12  Do you have any information that will help me prepare my 
submission or design my postmarket surveillance plan?
822.13  [Reserved]
822.14  May I reference information previously submitted instead of 
submitting it again?
822.15  How long must I conduct postmarket surveillance of my 
device?
Subpart D--FDA Review and Action
822.16  What will you consider in the review of my submission?
822.17  How long will your review of my submission take?
822.18  How will I be notified of FDA's decision?
822.19  What kinds of decisions may FDA make?
822.20  What are the consequences if I fail to submit a postmarket 
surveillance plan, my plan is disapproved and I fail to submit a new 
plan, or I fail to conduct surveillance in accordance with my 
approved plan?
822.21  What must I do if I want to make changes to my postmarket 
surveillance plan after you have approved it?
822.22  What recourse do I have if I do not agree with your 
decision?
822.23  Is the information in my submission considered confidential?
Subpart E--Responsibilities of Manufacturers
822.24  What are my responsibilities once I am notified that I am 
required to conduct postmarket surveillance?
822.25  What are my responsibilities after my postmarket 
surveillance plan has been approved?
822.26  If my company changes ownership, what must I do?
822.27  If I go out of business, what must I do?
822.28  If I stop marketing the device subject to postmarket 
surveillance, what must I do?
Subpart F--Waivers and Exemptions
822.29  May I request a waiver of a specific requirement of this 
part?
822.30  May I request exemption from the requirement to conduct 
postmarket surveillance?
Subpart G--Records and Reports
822.31  What records am I required to keep?
822.32  What records are the investigators in my surveillance plan 
required to keep?
822.33  How long must we keep the records?
822.34  What must I do with the records if the sponsor of the plan 
or an investigator changes?
822.35  Can FDA inspect my manufacturing site or other sites 
involved in my postmarketing surveillance plan?
822.36  Can FDA inspect and copy the records related to my 
postmarket surveillance plan?
822.37  Under what circumstances would FDA inspect records 
identifying subjects?
822.38  What reports must I submit to FDA?

    Authority: 21 U.S.C. 331, 352, 360l, 330l, 371.

Subpart A--General Provisions


Sec. 822.1  What does this part cover?

    This part implements section 522 of the Federal Food, Drug, and 
Cosmetic Act (the act) by providing procedures and requirements for 
postmarket surveillance of certain types of devices. If you fail to 
comply with requirements FDA orders under section 522 of the act and 
this part, your device is considered misbranded under section 502(t)(2) 
of the act and you are in violation of section 301(q)(1)(C) of the act.


Sec. 822.2  What is the purpose of this part?

    This purpose of this part is to implement our postmarket 
surveillance authority to maximize the likelihood that these postmarket 
plans will result in the collection of useful data. These data can 
reveal unforeseen adverse events, the actual rate of anticipated 
adverse events, and other information necessary to protect the public 
health.


Sec. 822.3  How do you define the terms used in this part?

    Some of the terms we use in this part are specific to postmarket 
surveillance and reflect the language used in the statute (law). Other 
terms are more general and reflect FDA's interpretation of the law. 
This section of the part defines the following terms:
    (a) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.), as amended.
    (b) Designated person means the individual who conducts or 
supervises the conduct of your postmarket surveillance. If your 
postmarket surveillance plan includes a team of investigators, as 
defined below, the designated person is the responsible leader of that 
team.

[[Page 52388]]

    (c) Device failure means a device does not perform or function as 
intended, and includes any deviation from the device's performance 
specifications or intended use.
    (d) General plan guidance means agency guidance that provides 
information about the requirement to conduct postmarket surveillance, 
the submission of a plan to the agency for approval, the content of the 
submission, and the conduct and reporting requirements of the 
surveillance.
    (e) Investigator means an individual who collects data or 
information in support of a postmarket surveillance plan.
    (f) Life-supporting or life-sustaining device used outside a device 
user facility means that a device is essential to, or yields 
information essential to, the restoration or continuation of a bodily 
function important to the continuation of human life and is used 
outside a hospital, nursing home, ambulatory surgical facility, or 
diagnostic or outpatient treatment facility. A physician's office is 
not a device user facility.
    (g) Manufacturer means any person, including any importer, 
repacker, and/or relabeler, who manufactures, prepares, propagates, 
compounds, assembles, processes, or engages in any of the activities 
described in Sec. 807.3(d) of this chapter.
    (h) Postmarket surveillance means the active, systematic, 
scientifically valid collection, analysis, and interpretation of data 
or other information about a marketed device.
    (i) Prospective surveillance means that the subjects are identified 
at the beginning of the surveillance and data or other information will 
be collected from that time forward (as opposed to retrospective 
surveillance).
    (j) Serious adverse health consequences means any significant 
adverse experience related to a device, including device-related events 
that are life-threatening or that involve permanent or long-term 
injuries or illnesses.
    (k) Specific guidance means guidance that provides information 
regarding postmarket surveillance for specific types or categories of 
devices or specific postmarket surveillance issues. This type of 
guidance may be used to supplement general guidance and may address 
such topics as the type of surveillance approach that is appropriate 
for the device and the postmarket surveillance question, sample size, 
or specific reporting requirements.
    (l) Surveillance question means the issue or issues to be addressed 
by the postmarket surveillance.
    (m) Unforeseen adverse event means any serious adverse health 
consequence that is either not addressed in the labeling of the device 
or occurs at a rate higher than anticipated.


Sec. 822.4  Does this part apply to me?

    If we have ordered you to conduct postmarket surveillance of a 
medical device under section 522 of the act, this part applies to you. 
We have the authority to order postmarket surveillance of any class II 
or class III medical device, including a device reviewed under the 
licensing provisions of section 351 of the Public Health Service Act, 
that meets any of the following criteria:
    (a) Failure of the device would be reasonably likely to have 
serious adverse health consequences;
    (b) The device is implanted in the human body for more than 1 year; 
or
    (c) The device is used to support or sustain life and is used 
outside a user facility.

Subpart B--Notification


Sec. 822.5  How will I know if I must conduct postmarket surveillance?

    We will send you a letter (the postmarket surveillance order) 
notifying you of the requirement to conduct postmarket surveillance. We 
may require that you submit information about your device that will 
allow us to better define the scope of a surveillance order. We will 
specify the device(s) subject to the surveillance order and the reason 
that we are requiring postmarket surveillance of the device under 
section 522 of the act. We will also provide you with any general or 
specific guidance that is available to help you develop your plan for 
conducting postmarket surveillance.


Sec. 822.6  When will you notify me that I am required to conduct 
postmarket surveillance?

    We will notify you as soon as we have determined that postmarket 
surveillance of your device is necessary, based on the identification 
of a surveillance question. This may occur during the review of a 
marketing application for your device, as your device goes to market, 
or after your device has been marketed for a period of time.


Sec. 822.7  What should I do if I do not agree that postmarket 
surveillance is appropriate?

    If you do not agree with our decision to order postmarket 
surveillance for a particular device, there are a number of mechanisms 
you may use to request review of our decision. These include:
    (a) Requesting a meeting with the Director, Office of Surveillance 
and Biometrics, Center for Devices and Radiological Health, who 
generally issues the order for postmarket surveillance;
    (b) Seeking internal review of the order under 21 CFR 10.75;
    (c) Requesting an informal hearing under 21 CFR part 16; or
    (d) Requesting review by the Medical Devices Dispute Resolution 
Panel of the Medical Devices Advisory Committee.

Subpart C--Postmarket Surveillance Plan


Sec. 822.8  When, where, and how must I submit my postmarket 
surveillance plan?

    You must submit your plan to conduct postmarket surveillance within 
30 days of the date you receive the postmarket surveillance order. For 
devices regulated by the Center for Devices and Radiological Health, 
you should send three copies of your submission to the Center for 
Devices and Radiological Health, Postmarket Surveillance Document 
Center (HFZ-510), 1350 Piccard Dr., Rockville, MD, 20850. For devices 
regulated by the Center for Biologics Evaluation and Research, you 
should send three copies of your submission to Center for Biologics 
Evaluation and Research, Document Control Center, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448. When we receive your original 
submission, we will send you an acknowledgement letter identifying the 
unique document number assigned to your submission. You should use this 
number in any correspondence related to this submission.


Sec. 822.9  What must I include in my submission?

    Your submission must include the following:
    (a) Organizational/administrative information:
    (1) Your name and address;
    (2) Generic and trade names of your device;
    (3) Name and address of the contact person for the submission;
    (4) Premarket application/submission numbers for your device;
    (5) Table of contents identifying the page numbers for each section 
of the submission;
    (6) Description of the device (this may be incorporated by 
reference to the appropriate premarket application/submission);
    (7) Product codes and a list of all relevant model numbers; and

[[Page 52389]]

    (8) Indications for use and claims for the device;
    (b) Postmarket surveillance plan;
    (c) Designated person information:
    (1) Name, address, and telephone number; and
    (2) Experience and qualifications.


Sec. 822.10  What must I include in my surveillance plan?

    Your surveillance plan must include a discussion of:
    (a) The plan objective(s) addressing the surveillance question(s) 
identified in our order;
    (b) The subject of the study, e.g., patients, the device, animals;
    (c) The variables and endpoints that will be used to answer the 
surveillance question, e.g., clinical parameters or outcomes;
    (d) The surveillance approach or methodology to be used;
    (e) Sample size and units of observation;
    (f) Sources of data, e.g., hospital records;
    (g) The data collection plan and forms;
    (h) The patient followup plan, if applicable;
    (i) The procedures for monitoring conduct and progress of the 
surveillance;
    (j) An estimate of the duration of surveillance;
    (k) All data analyses and statistical tests planned; and
    (l) The content and timing of reports.


Sec. 822.11  What should I consider when designing my plan to conduct 
postmarket surveillance?

    You must design your surveillance to address the postmarket 
surveillance question identified in the order you received. You should 
also consider the function, operating characteristics, and intended use 
of your device when designing a surveillance approach.


Sec. 822.12  Do you have any information that will help me prepare my 
submission or design my postmarket surveillance plan?

    We have issued guidance for the development of postmarket 
surveillance plans which discusses the contents of a plan and points to 
consider in developing one. We have also issued guidance on criteria 
and approaches for postmarket surveillance, which discusses the 
criteria that we use to determine when postmarket surveillance under 
section 522 of the act is appropriate and necessary. The guidance 
identifies and discusses a broad range of surveillance approaches and 
describes the circumstances for which each would be suitable. These 
guidance documents are available on the Internet and from the Center 
for Devices and Radiological Health, Office of Surveillance and 
Biometrics (HFZ-510), 1350 Piccard Dr., Rockville, MD 20850.


Sec. 822.13  [Reserved]


Sec. 822.14  May I reference information previously submitted instead 
of submitting it again?

    Yes, you may reference information that you have submitted in 
premarket submissions as well as other postmarket surveillance 
submissions. You must specify the information to be incorporated and 
the document number and pages where the information is located.


Sec. 822.15  How long must I conduct postmarket surveillance of my 
device?

    The length of postmarket surveillance will depend on the postmarket 
surveillance question identified in our order. We may order prospective 
surveillance for a period up to 36 months; longer periods require your 
agreement. If we believe that a prospective period of greater than 36 
months is necessary to address the surveillance question, and you do 
not agree, we will use our dispute resolution procedures.

Subpart D--FDA Review and Action


Sec. 822.16  What will you consider in the review of my submission?

    First, we will determine that the submission is administratively 
complete. Then, in accordance with the law, we must determine whether 
the designated person has appropriate qualifications and experience to 
conduct the surveillance and whether the surveillance plan will result 
in the collection of useful data that will answer the surveillance 
question.


Sec. 822.17  How long will your review of my submission take?

    We will review your submission within 60 days of receipt.


Sec. 822.18  How will I be notified of FDA's decision?

    We will send you a letter notifying you of our decision and 
identifying any action you must take.


Sec. 822.19  What kinds of decisions may FDA make?

 
----------------------------------------------------------------------------------------------------------------
            If your plan:                    Then we will send you:                     And you must:
----------------------------------------------------------------------------------------------------------------
(a) Should result in the collection   An approval order, identifying any    Conduct postmarket surveillance of
 of useful data that will address      specific requirements related to      your device in accordance with the
 the postmarket surveillance           your postmarket surveillance          approved plan.
 question
(b) Should result in the collection   An approvable letter identifying the  Revise your postmarket surveillance
 of useful data that will address      specific revisions or information     submission to address the concerns
 the postmarket surveillance           that must be submitted before your    in the approvable letter and submit
 question after specific revisions     plan can be approved                  it to us within the specified
 are made or specific information is                                         timeframe. We will determine the
 provided                                                                    timeframe case by case, based on
                                                                             the types of revisions or
                                                                             information that you must submit.
(c) Does not meet the requirements    A letter disapproving your plan and   Revise your postmarket surveillance
 specified in this part                identifying the reasons for           submission and submit it to us
                                       disapproval                           within the specified timeframe. We
                                                                             will determine the timeframe case
                                                                             by case, based on the types of
                                                                             revisions or information that you
                                                                             must submit.
(d) Is not likely to result in the    A letter disapproving your plan and   Revise your postmarket surveillance
 collection of useful data that will   identifying the reasons for           submission and submit it to us
 address the postmarket surveillance   disapproval                           within the specified timeframe. We
 question                                                                    will determine the timeframe case
                                                                             by case, based on the types of
                                                                             revisions or information that you
                                                                             must submit.
----------------------------------------------------------------------------------------------------------------


[[Page 52390]]

Sec. 822.20  What are the consequences if I fail to submit a postmarket 
surveillance plan, my plan is disapproved and I fail to submit a new 
plan, or I fail to conduct surveillance in accordance with my approved 
plan?

    The failure to have an approved postmarket surveillance plan or 
failure to conduct postmarket surveillance in accordance with the 
approved plan constitutes failure to comply with section 522 of the 
act. Your failure would be a prohibited act under section 301(q)(1)(B) 
of the act, and your device would be misbranded under section 502(t)(2) 
of the act. This means that we could seek to impose a number of 
penalties, including civil money penalties, criminal penalties, seizure 
of your products, or court injunction against further marketing of your 
device.


Sec. 822.21  What must I do if I want to make changes to my postmarket 
surveillance plan after you have approved it?

    You must submit a request to make the proposed change and a revised 
postmarket surveillance plan (if needed) and receive our approval prior 
to making changes in your plan. You should identify this as a 
supplement to your postmarket surveillance submission, citing the 
unique document number that we assigned, and specifically identify the 
changes to the plan and the reasons/justification for making the 
changes in your cover letter.


Sec. 822.22  What recourse do I have if I do not agree with your 
decision?

    If you disagree with us about the content of your plan or if we 
disapprove your plan, there are a number of mechanisms you may use to 
request review of our decision. These include:
    (a) Requesting a meeting with the Director, Office of Surveillance 
and Biometrics, Center for Devices and Radiological Health, who 
generally issues the order for postmarket surveillance;
    (b) Seeking internal review of the order under 21 CFR 10.75;
    (c) Requesting an informal hearing under 21 CFR part 16; or
    (d) Requesting review by the Medical Devices Dispute Resolution 
Panel of the Medical Devices Advisory Committee.


Sec. 822.23  Is the information in my submission considered 
confidential?

    We consider the content of your submission confidential until we 
have approved your postmarket surveillance plan. After we have approved 
your plan, the contents of the original submission and any amendments, 
supplements, or reports may be disclosed in accordance with the Freedom 
of Information Act. We will continue to protect trade secret and 
confidential commercial information after your plan is approved. We 
will not disclose information identifying individual patients. You may 
wish to indicate in your submission which information you consider 
trade secret or confidential commercial.

Subpart E--Responsibilities of Manufacturers


Sec. 822.24  What are my responsibilities when I am notified that I am 
required to conduct postmarket surveillance?

    You must submit your plan to conduct postmarket surveillance to us 
within 30 days from receipt of the order (letter) notifying you that 
you are required to conduct postmarket surveillance of a device.


Sec. 822.25  What are my responsibilities after my postmarket 
surveillance plan has been approved?

    After we have approved your plan, you must conduct the postmarket 
surveillance of your device in accordance with your approved plan. This 
means that you must ensure that:
    (a) Postmarket surveillance is initiated in a timely manner;
    (b) The surveillance is conducted in a scientifically sound manner 
and with due diligence;
    (c) The data identified in the plan is collected;
    (d) Any reports required as part of your approved plan are 
submitted to the agency in a timely manner; and
    (e) Any information that we request prior to your submission of a 
report or in response to our review of a report is provided in a timely 
manner.


Sec. 822.26  If my company changes ownership, what must I do?

    You must notify us within 30 days of any change in ownership of 
your company. Your notification should identify any changes to the name 
or address of the company, the contact person, or the designated person 
(as defined in Sec. 822.3(b)). Your obligation to conduct postmarket 
surveillance will generally transfer to the new owner, unless you have 
both agreed that you will continue to conduct the surveillance. If you 
will continue to conduct the postmarket surveillance, you still must 
notify us of the change in ownership.


Sec. 822.27  If I go out of business, what must I do?

    You must notify us within 30 days of the date of your decision to 
close your business. You should provide the expected date of closure 
and discuss your plans to complete or terminate postmarket surveillance 
of your device. You must also identify who will retain the records 
related to the surveillance (described in subpart G of this part) and 
where the records will be kept.


Sec. 822.28  If I stop marketing the device subject to postmarket 
surveillance, what must I do?

    You must continue to conduct postmarket surveillance in accordance 
with your approved plan even if you no longer market the device. You 
may request that we allow you to terminate postmarket surveillance or 
modify your postmarket surveillance because you no longer market the 
device. We will make these decisions on a case-by-case basis, and you 
must continue to conduct the postmarket surveillance unless we notify 
you that you may stop your surveillance study.

Subpart F--Waivers and Exemptions


Sec. 822.29  May I request a waiver of a specific requirement of this 
part?

    You may request that we waive any specific requirement of this 
part. You may submit your request, with supporting documentation, 
separately or as a part of your postmarket surveillance submission to 
the address in Sec. 822.7.


Sec. 822.30  May I request exemption from the requirement to conduct 
postmarket surveillance?

    You may request exemption from the requirement to conduct 
postmarket surveillance for your device or any specific model of that 
device at any time. You must comply with the requirements of this part 
unless and until we grant an exemption for your device. Your request 
for exemption must explain why you believe we should exempt the device 
or model from postmarket surveillance. You should demonstrate why the 
surveillance question does not apply to your device or does not need to 
be answered for the device for which you are requesting exemption. 
Alternatively, you may provide information that answers the 
surveillance question for your device with supporting documentation to 
the address in Sec. 822.7.

Subpart G--Records and Reports


Sec. 822.31  What records am I required to keep?

    You must keep copies of:
    (a) All correspondence with your investigators or FDA, including 
required reports;
    (b) Signed agreements from each of your investigators, when 
applicable, stating the commitment to conduct the surveillance in 
accordance with the

[[Page 52391]]

approved plan, any applicable FDA regulations, and any conditions of 
approval for your plan, such as reporting requirements;
    (c) Your approved postmarket surveillance plan, with documentation 
of the date and reason for any deviation from the plan;
    (d) All data collected and analyses conducted in support of your 
postmarket surveillance plan; and
    (e) Any other records that we require to be maintained by 
regulation or by order.


Sec. 822.32  What records are the investigators in my surveillance plan 
required to keep?

    Your investigator must keep copies of:
    (a) All correspondence with another investigator, FDA, or you, 
including required reports.
    (b) The approved postmarket surveillance plan, with documentation 
of the date and reason for any deviation from the plan.
    (c) All data collected and analyses conducted for postmarket 
surveillance.
    (d) Any other records that we require to be maintained by 
regulation or by order.


Sec. 822.33  How long must we keep these records?

    You and your investigators must keep all records for a period of 2 
years after we have accepted your final report, unless we specify 
otherwise.


Sec. 822.34  What must I do with the records if the sponsor of the plan 
or an investigator in the plan changes?

    If the sponsor of the plan or an investigator in the plan changes, 
you must ensure that all records related to the postmarket surveillance 
have been transferred to the new sponsor or investigator and notify us 
within 10 days of the effective date of the change. You must provide 
the name, address, and telephone number of the new sponsor or 
investigator, certify that all records have been transferred, and 
provide the date of transfer.


Sec. 822.35  Can FDA inspect my manufacturing site or other sites 
involved in my postmarket surveillance plan?

    We can review your postmarket surveillance programs during 
regularly scheduled inspections, inspections initiated to investigate 
recalls or other similar actions, and inspections initiated 
specifically to review your postmarket surveillance plan. We may also 
inspect any other person or site with postmarket surveillance 
obligations, such as clinical investigators or contractors. Any person 
authorized to grant access to a facility must permit authorized FDA 
employees to enter and inspect any facility where the device is held or 
where records regarding postmarket surveillance are held.


Sec. 822.36  Can FDA inspect and copy the records related to my 
postmarket surveillance plan?

    We may, at a reasonable time and in a reasonable manner, inspect 
and copy any records pertaining to the conduct of postmarket 
surveillance that are required to be kept by this part. You must be 
able to produce records and information required by this part that are 
in the possession of others under contract with you to conduct the 
postmarket surveillance. We also expect those who have signed 
agreements or are under contract with you to produce the records and 
information upon our request. This information must be produced within 
72 hours of the initiation of the inspection. We generally will redact 
information pertaining to individual subjects prior to copying those 
records, unless there are extenuating circumstances.


Sec. 822.37  Under what circumstances would FDA inspect records 
identifying subjects?

    We can inspect and copy records identifying subjects under the same 
circumstances that we can inspect any records relating to postmarket 
surveillance. The agency is likely to be interested in such records if 
we have reason to believe that required reports have not been 
submitted, or are incomplete, inaccurate, false, or misleading.


Sec. 822.38  What reports must I submit to FDA?

    You must submit interim and final reports as specified in your 
approved postmarket surveillance plan. In addition, we may ask you to 
submit additional information when we believe that the information is 
necessary for the protection of the public health and implementation of 
the act. We will also state the reason or purpose for the request and 
how we will use the information.

    Dated: August 18, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-21827 Filed 8-28-00; 8:45 am]
BILLING CODE 4160-01-F