[Federal Register Volume 67, Number 109 (Thursday, June 6, 2002)]
[Rules and Regulations]
[Pages 38878-38892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14100]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is implementing the 
postmarket surveillance (PS) provisions of the Federal Food, Drug, and 
Cosmetic Act (the act), as amended by the Food and Drug Administration 
Modernization Act of 1997 (FDAMA). The purpose of this rule is to 
provide for the collection of useful data about devices that can reveal 
unforeseen adverse events or other information necessary to protect the 
public health.

DATES: This rule is effective July 8, 2002.

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?
II. What Comments Did FDA Receive on the Proposed Rule? How Did These 
Comments Affect the Final Rule?
    A. Organization and Format
    B. General Comments
    C. Notification
    D. Postmarket Surveillance Plan
    E. FDA Review and Action
    F. Records and Reports
    G. Economic Impact
    H. Paperwork Reduction Act
III. What Is the Economic Impact of This Regulation?
    A. Introduction
    B. Objective of the Regulation
    C. Risk Assessment/Baseline Conditions
    D. Costs of Postmarket Surveillance
    E. Benefits of the Regulation
    F. Annual Costs and Benefits of the Regulation
    G. Small Business Analysis/Regulatory Flexibility Analysis
    H. Conclusions
IV. How Does This Regulation Comply With the Paperwork Reduction Act of 
1995?

I. What Is the Background of This Rulemaking?

    In the Federal Register of August 29, 2000 (65 FR 52376), we (FDA) 
published a proposed rule implementing the PS provisions in section 522 
(21 U.S.C. 360l) of the act, as amended by FDAMA. We provided a period 
of 90 days for comments from interested parties. We received comments 
from four entities. We summarize and discuss these comments below, and 
we have revised the final rule appropriately.

II. What Comments Did FDA Receive on the Proposed Rule? How Did These 
Comments Affect the Final Rule?

A. Organization and Format

    (Comment 1) We received several comments commending the use of 
plain English, logical formatting, and the question and answer style.
    We appreciate the positive comments and will continue to use the 
plain English concepts.

B. General Comments

    (Comment 2) One comment suggested that Sec.  822.1 be revised to 
include the statutory criteria for imposing PS. This would make the 
scope of the regulation clearer.
    We agree, and have modified Sec. 822.1 accordingly.
    (Comment 3) Several comments expressed concern that the proposed 
rule would impose substantial, unnecessary burdens on device 
manufacturers, and proposed a number of changes that would reduce the 
burden. Individual changes are addressed in the appropriate regulation 
sections. One comment stated that existing systems, such as medical 
device reports (MDRs), are adequate to provide safety and effectiveness 
information.
    We do not agree. If Congress thought that existing mechanisms were 
sufficient, it would not have provided for PS. We recognize the 
potential for PS to be burdensome, but do not agree that any burden 
imposed by PS would be unnecessary. We intend to impose PS only when 
necessary to address a postmarket public health question. We also 
intend to work with the affected manufacturer(s) to identify the least 
burdensome approach that will adequately address the surveillance 
question.
    (Comment 4) Two comments stated that FDA does not have the 
authority to require clinical studies, citing the legislative history 
of FDAMA and the changes in language in the act from ``protocol'' to 
``plan'' and ``investigator'' to ``designated person.''
    We disagree. As originally enacted in the Safe Medical Devices Act 
of 1990 (SMDA), PS under section 522 of the act was automatically 
required for certain devices, and the statutory language allowed little 
flexibility in designing a PS study. In FDAMA, Congress eliminated this 
automatic PS, giving FDA discretion to require PS when appropriate, and 
also gave FDA greater discretion in crafting the form of the 
surveillance. This broader discretion means that we can accept PS plans 
that are less rigorous (and less burdensome) than clinical studies, 
such as literature reviews and analyses of complaint information. The 
agency expects that it would rarely if ever demand an adequate and 
well-controlled double-blind clinical trial as the only means of 
collecting clinical data to satisfy a PS requirement. On the other 
hand,

[[Page 38879]]

collection of clinical data may take many forms, and the agency 
continues to believe that prospective clinical data will be necessary 
in about 10 percent of all instances of PS. Congress addressed its 
concern that FDA not require burdensome longitudinal studies not by 
prohibiting clinical studies altogether but by limiting the duration of 
any PS study to 3 years unless manufacturers agree to a longer period. 
If no agreement can be reached, the dispute resolution process 
described in section 562 of the act (21 U.S.C. 360 bbb-1) will be used 
to resolve issues related to duration. This time limit on PS is 
incorporated into our regulations. Thus while FDAMA gave FDA power to 
eliminate unnecessary burden from PS, it does not prohibit us from 
requiring clinical studies where necessary to protect the public health 
and where conducted within applicable time limits.
    (Comment 5) Two comments expressed concern that we intend to 
increase the amount of data required to support a new indication for 
use by imposing PS.
    We do not intend to impose PS for every new indication for use, nor 
do we expect imposition of PS to increase the data requirements for a 
new indication for use. Instead, we expect PS to be used in some 
instances to shift some data collection from pre- to postmarket, 
allowing a device to reach the market sooner. For example, this 
mechanism could be used for a device that is going from clinical use to 
home use.

C. Notification

    (Comment 6) Two comments stated that PS orders should contain the 
justification for selecting PS over other, less burdensome 
alternatives.
    We agree that PS should not be imposed without considering less 
burdensome alternatives. Our guidance document entitled ``Criteria and 
Approaches for Postmarket Surveillance'' (www.fda.gov/cdrh/modact/critappr.pdf) discusses our present thinking on this and other criteria 
that we will use to determine whether to impose PS. We consider this 
justification part of the ``reason that we are requiring postmarket 
surveillance'' that will be contained in a PS order, so there is no 
need to modify Sec. 822.5.
    (Comment 7) One comment objected to the application of PS to in 
vitro diagnostic (IVD) biologics, stating that these devices are 
already under PS, including lot release, reporting changes, and 
reporting errors.
    We acknowledge that there are other PS requirements for IVD 
biologics, and it is not intended that PS duplicate or supersede any 
existing requirements. We would take these existing requirements into 
consideration when evaluating whether and what form of PS is the 
appropriate mechanism for addressing the PS question.
    (Comment 8) Several comments stated that FDA should be required to 
meet with manufacturers prior to issuing a PS order, to discuss whether 
PS is necessary or whether our concerns could be addressed by other, 
less burdensome mechanisms.
    As noted in the preamble to the proposed rule, we anticipate 
meeting with the affected manufacturer(s) prior to issuing a 
surveillance order for a particular device for the first time. A 
requirement that we meet with affected manufacturers prior to issuing 
subsequent orders for the same device would be burdensome for 
manufacturers as well as for FDA. We are, therefore, retaining the 
flexibility to issue PS orders without first meeting with the affected 
manufacturer(s).
    (Comment 9) Several comments urged FDA to modify the rule or issue 
guidance to advise manufacturers as to what sort of devices may be 
subject to PS. Knowledge of PS requirements would be an important 
consideration for a manufacturer contemplating entering a specific 
market. It was also suggested that we maintain an Internet Web page 
that lists devices for which PS has been ordered.
    We acknowledge that the possibility that PS may be required for a 
particular device may influence a manufacturer's decision to enter a 
particular market. There are, currently, few devices subject to PS. We 
cannot predict which specific devices may be subject to PS in the 
future. A PS order is issued to address a specific PS question, which 
may surface at any time in the device's life cycle. The guidance 
document entitled ``Criteria and Approaches for Postmarket 
Surveillance'' discusses the criteria we will use to determine whether 
to impose PS. We will publish a list of devices subject to PS and make 
it available through the Internet and Facts-on-Demand.

D. Postmarket Surveillance Plan

    (Comment 10) We received several comments that questioned whether 
domestic manufacturers of devices for export only should be subject to 
PS. These devices cannot be marketed in the United States and it is 
illogical to impose PS on these products.
    We agree. Devices manufactured for export only, in compliance with 
section 801(e) of the act (21 U.S.C. 381(e)), are subject to the 
requirements of the importing country and will not be subject to PS 
under this rule.
    (Comment 11) We received two comments that we should modify the 
rule to utilize a ``two-tier'' system for PS. The first tier would 
involve the manufacturer collecting information regarding significant 
complications, using selected centers and clinical report forms. If the 
first tier resulted in identification of a specific question, i.e., 
unexpected serious illness, the second tier would involve a more in-
depth information collection. If no specific question were identified, 
PS would be considered complete.
    We do not agree that a ``two-tier'' approach is more likely to 
generate useful information. The ``two-tier'' approach assumes no 
information is available regarding significant complications. We do not 
intend to impose PS unless we have identified a need for information or 
data. This need may be identified during the review of a marketing 
application or after the device has been marketed. For devices already 
on the market, PS may be ordered to collect information about an 
unanticipated adverse event. We believe that the ``two-tiered'' 
approach suggested by the comments would actually be more burdensome 
for manufacturers, since it would require data collection in the 
absence of a clearly defined need. We do agree that the results of a PS 
plan may, in some cases, raise new questions that may need to be 
addressed by a second PS plan. The rule, as written, allows for, but 
does not require, a two-tiered approach.
    (Comment 12) We received two comments about the applicability of 
regulations concerning informed consent (part 50 (21 CFR part 50)) and 
institutional review boards (IRBs) (part 56 (21 CFR part 56)). They 
noted that PS is not within the scope of part 50 or part 56, and that 
only a very limited consent involving confidentiality of patient 
records is appropriate.
    These comments agree with our statements in the preamble to the 
proposed rule. We agree that informed consent under part 50 and IRB 
review under part 56 are not applicable to many PS plans. However, 
there are surveillance plan designs, e.g., a prospective, clinically-
based data collection, under which some or all of the provisions of 
parts 50 and 56 would be appropriate. Other designs, e.g., a registry 
maintained by a manufacturer, may require modification to the patient 
consent form to indicate that data may be provided to FDA. We do not 
require, nor do we generally expect, PS to result in the collection of 
personal identifiers. In any PS plan, we expect the manufacturer to 
ensure that the

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surveillance approach used incorporates whatever measures are necessary 
to protect patient privacy. We will ensure that the appropriate patient 
protection measures are in place through the review and approval of 
each PS plan.
    (Comment 13) One comment requested clarification of our requirement 
(Sec. 822.9(a)(8)) that the PS plan include the indications for use and 
claims for the device. The comment asked if we intended for the 
manufacturer to submit copies of all labeling and promotional materials 
for the device.
    We do not expect copies of all labeling and promotional material to 
be included in the submission. This information may be incorporated by 
reference to another submission, including a marketing application. In 
general, you may submit a statement of any claims that are relevant to 
the performance of the device, rather than copies of promotional 
materials.
    (Comment 14) One comment stated that the incorporation of guidance 
as substance in Sec. 822.12 violated notice and comment requirements.
    We do not agree that Sec. 822.12 incorporates guidance as 
substance. This section of the proposed rule referred the reader to two 
current guidance documents in response to the question, ``Do you have 
any information that will help me prepare my submission or design my 
postmarket surveillance plan?'' Guidance documents represent the 
agency's current interpretation of, or policy on, a regulatory issue. 
They do not establish legally enforceable rights or responsibilities 
and do not legally bind the public or FDA. You may choose to use an 
approach other than the one set forth in a guidance document, as long 
as your alternative approach complies with the relevant statutes and 
regulations.
    Nonetheless, to avoid confusion and to ensure that the regulations 
do not become outdated should the agency revise its guidance documents, 
we have revised Sec. 822.12 and other references to guidance documents 
in the regulations to alert the reader to the availability of guidance 
generally, and have clarified the role of guidance documents in 
relation to specific regulatory and statutory requirements.

E. FDA Review and Action

    (Comment 15) Two comments asked that we identify the criteria we 
will use for evaluating PS plans and define the term ``scientific 
soundness.''
    The regulation states that, among other things, we will evaluate 
whether the PS plan is likely to provide useful information that will 
address the PS question. Specific criteria will depend on the 
surveillance question and the approach used. We intend to provide the 
affected manufacturer(s) with as much guidance as possible and we 
expect the review of a PS plan to be interactive. ``Scientific 
soundness'' indicates that a plan was developed using scientific 
principles. We expect a clearly defined hypothesis and a plan that can 
reasonably be expected to develop data that will address the 
hypothesis.
    (Comment 16) Two comments objected to the requirement that any 
changes to an approved PS plan be submitted to and approved by us prior 
to making the change. The comments suggested that we should only 
require prior submission and approval of ``significant'' changes, i.e., 
those that would affect the nature of data collected in accordance with 
the plan.
    We agree. We have modified Sec. 822.21 to indicate that only 
changes that will affect the nature or validity of data collected in 
accordance with the plan require prior approval. Such changes are those 
for which a revised surveillance plan will be needed, and we have 
modified the section to clarify this, as well as to emphasize that in 
preparing the revised plan, you may reference information submitted in 
your approved surveillance plan or other submissions, in accordance 
with Sec. 822.14. Changes that will not affect the nature or validity 
of data collected in accordance with the plan must be reported in the 
next interim report required by your approval order. No revised 
surveillance plan is needed for such changes.
    We have altered Sec. 822.21 to clarify the number of copies of a 
change request that should be submitted, and the address to which they 
should be sent.
    (Comment 17) One comment suggested that the language concerning 
confidentiality in Sec. 822.23 was not clear and that it should be 
revised to indicate that we will not disclose the contents of a 
submission before the plan is approved and that we will not disclose 
confidential information.
    We agree and have revised Sec. 822.23 accordingly.
    (Comment 18) Two comments objected to the disclosure of PS plans, 
amendments, supplements, and reports under the Freedom of Information 
Act (FOIA) once the PS plan is approved. Both comments stated that the 
contents of the submissions should be confidential until the 
manufacturer's final report is submitted. Early disclosure could 
provide competitors with commercially sensitive information.
    Under FOIA, we have no basis for continuing to hold a PS plan 
confidential in its entirety once it has been approved. As noted in the 
rule, the submission will remain confidential until the plan is 
approved, and we will continue to protect the confidentiality of trade 
secret or confidential commercial information, or information 
identifying patients.

F. Records and Reports

    (Comment 19) Two comments suggested that PS program inspections be 
subject to FDA's ``Preannounced Inspection Policy.''
    Policies and procedures concerning the planning and conduct of 
inspections are not within the scope of this regulation. We believe 
that PS program inspections should be conducted in accordance with 
policies and procedures in place at the time of the inspection.
    (Comment 20) One comment stated that the reporting requirements are 
not authorized by the PS provisions in the act and that they are unduly 
burdensome, in contravention of section 519(a)(4) of the act (21 U.S.C. 
360i(a)(4)).
    We do not agree. We have ample authority to establish these 
requirements. These PS regulations are authorized under section 701(a) 
of the act (21 U.S.C. 371(a)) because they establish recordkeeping and 
reporting requirements that are necessary for FDA to verify that 
devices comply with PS orders issued under section 522 of the act. As 
explained in the preamble to our proposed regulation, these regulations 
are also authorized by section 519 of the act, which permits FDA to 
establish by regulation reporting requirements necessary to assure that 
a device is not misbranded, because a device that does not comply with 
a section 522 of the act PS plan is misbranded under section 502(t) of 
the act (21 U.S.C. 352(t)). In light of the public health benefits 
achieved by compliance with PS orders, these recordkeeping and 
reporting requirements are not unduly burdensome. Our analyses under 
the Paperwork Reduction Act of 1995 (the PRA) and of the economic 
impact address the annual recordkeeping and reporting burdens imposed 
by these regulations in detail and demonstrate that they are not unduly 
burdensome.

G. Economic Impact

    (Comment 21) One comment objected to the idea that manufacturers 
would conduct PS plans involving 30,000 subjects, stating that our 
concept of PS is unrealistic.

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    We agree that a PS plan calling for 30,000 observations is 
unrealistic. It was not our intent to suggest that PS plans of this 
size would be required; instead the example demonstrates that PS to 
detect very rare events would be impractical, if not impossible.
    (Comment 22) One comment argued that we do not have the authority 
to require clinical studies.
    We do not agree. As discussed under section II.B of this document, 
``General Comments,'' we do not believe that the statutory language 
precludes us from ordering PS that involves clinical data collection. 
We do not anticipate that clinical studies will be required for a 
significant number of PS plans. The estimates used in section II.G of 
this document, ``Economic Impact'' are intended to yield an over-
estimate of the cost of PS.
    (Comment 23) One comment stated that, while the guidance document 
entitled ``Criteria and Approaches for Postmarket Surveillance'' 
provides some examples, more specificity is needed for determining when 
different types of data collection might be used.
    We agree that a clear understanding of the type of data collection 
appropriate for PS would be useful to a prospective manufacturer of a 
device. While this information may be available for a device already 
subject to PS, we cannot predict what surveillance questions may arise 
in the future and therefore cannot identify what type of data 
collection would be most appropriate to address the surveillance 
question. As we gain more experience with PS under section 522 of the 
act, we may be able to provide additional guidance.
    (Comment 24) One comment objected to an estimated cost of $324,000 
for a plan requiring primary data collection, believing that the cost 
would be significantly higher. The comment asks that we clarify how we 
arrived at the various cost estimates.
    We acknowledge that precise costs may vary by specific PS order, 
but believe the costs are reasonable representations of typical 
clinical data collection efforts. As detailed for the proposed rule, we 
have attempted to provide reasonable descriptions of cost elements for 
a 36-month investigation. We have not received any data that refute the 
cost estimates.
    (Comment 25) One comment questioned the identification of the 
categories of devices that are likely to be affected by the rule.
    The categories\1\ used in the Small Business and Regulatory 
Flexibility analyses are those used by the Census Bureau. While these 
categories do not coincide with either the class or medical specialty 
designations that we use to classify devices, they do include the 
majority of medical device manufacturers. These categories were used to 
estimate the proportion of medical device manufacturers that would be 
designated ``small businesses.'' Although the percentages varied 
slightly, the business size for all of the categories cited was 
overwhelmingly ``small.'' Therefore, the economic analysis assumed that 
the majority of manufacturers affected by this regulation would be 
considered ``small businesses.''
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    \1\The categories and percentages have been updated in this 
final rule to indicate more recent data for the current 
classification system used by the Census Bureau, the North American 
Industries Codes (NAIC). The slight changes in the categories and 
numbers do not affect our conclusion that the majority of device 
manufacturers likely to be affected by this rule are small entities.
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H. Paperwork Reduction Act

    (Comment 26) Two comments noted that the collection of information 
is unnecessary for devices manufactured for export only and for minor 
changes to an approved PS plan.
    We agree, and have modified the regulation accordingly, as noted 
under ``Postmarket Surveillance Plan'' (devices for export only) and 
``FDA Review and Action'' (changes to approved PS plan).
    (Comment 27) Two comments contained suggestions to enhance the 
quality, utility, and clarity of information collected under the PS 
rule.
    The first suggestion, that we be required to meet with the affected 
manufacturer(s) prior to issuing a PS order, is discussed in section 
II.C of this document, ``Notification.'' The second suggestion, that we 
provide more guidance as to what we expect in a PS plan and the 
criteria that will be used in evaluating the plan, has been addressed 
in section II.E of this document, ``FDA Review and Action.''

III. What is the Economic Impact of This Regulation?

A. Introduction

    We have examined the impact of the regulations 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). We believe that this final rule is consistent with the 
regulatory philosophy and principles identified in the Executive order. 
This final rule, however, is not a significant regulatory action as 
defined by the Executive order.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. This rule is likely to have potential significant impacts on 
substantial numbers of small entities. We have included a Final 
Regulatory Flexibility Analysis at the end of this section. Finally, 
this regulation will not impose costs of $100 million or more in any 
one year on either the private sector or State, local, and tribal 
governments in the aggregate, and therefore we are not required to 
prepare a summary statement of analysis under section 202(a) of UMRA.

B. Objective of the Regulation

    The objective of the regulation 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 regulation 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 serious, device-related adverse 
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 regulation, 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 that 
either: (1) Are intended to be implanted in the human body for more 
than 1 year; (2) are life-sustaining or life-supporting and used 
outside a device user facility; or (3) for which failure could be 
reasonably likely to have serious adverse health consequences. Devices 
with these characteristics range from implantable pacemaker pulse 
generators and vascular graft prostheses to dental and orthopedic 
implants.

[[Page 38882]]

    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 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 for dozens, if not hundreds, of patients when 
a device is marketed to thousands of patients. Postmarket surveillance 
provides a mechanism for gaining an early awareness and better 
understanding of such relatively 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. 
Although SMDA granted us the authority to require surveillance, and 
FDAMA maintained it, there is currently no specific mechanism for 
conducting this 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 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 (one event in 
10,000 patients). The PS designed to detect more frequent events 
requires fewer observations. The surveillance must include about 1,800 
observations to be 95 percent confident that PS will detect events that 
occur at a frequency of 0.002 (two events in 1,000 patients). 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 databases or sources (such as 
Medicare databases, 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.
1. 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 BLS, in 
1997 the median weekly rate of compensation for managerial and 
professional personnel in this industry group (NAIC339112) 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.
2. Costs of Data Collection
    a. 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. 
Based on the experience of the National Cancer Institute in 
administering grants for similar research the typical cost per clinical 
observation to collect patient data is approximately $150. 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 such opportunity costs for procedures and 
tests that provide him or her no direct benefit. We have estimated that 
PS clinical studies may require

[[Page 38883]]

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 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.
    b. 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 surveillance. Based on typical costs we 
have experienced for acquisition of similar databases, 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 assure 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.
    c. 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 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 for 3 
years, the present value of the costs of this data collection equals 
$38,000.
3. 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.
4. Total Private Costs of Postmarket Surveillance
    The annual cost 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.
5. 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 additional review full-time 
employee (FTE) resources to oversee the program. In addition, we would 
require an additional 2.5 FTE's in support and management resources. We 
have estimated that the loaded 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.
6. 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 manufacturers while $0.9 million are our 
costs of operating the program.

E. Benefits of the Regulation

    The expected benefit of the regulation is the reduction in 
avoidable adverse events attributable to the early 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 
regulation had been in place.
1. 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

[[Page 38884]]

failed. No failures were reported in 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 be 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 semi-annual patient observations 
after three years (12 / 102,000 = .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. Close attention would have been paid to all adverse events 
(both expected and unexpected), with special attention being 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.
2. PS and Risk Reduction
    If PS prevented 63 percent of the actual implants (52,000/82,000), 
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.
3. 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.
4. 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 regulation 
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 10\th\ 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 
one 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 regulation is expected to 
equal 95 percent of the total amount, or $182.4 million.
5. Annual Benefits of the Regulation
    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 on-going 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.
    Of course, we believe the regulations will result in other 
benefits, such as reductions in psychological stress and worry 
associated with device failures and the avoidance of morbidities or 
medical procedures required by non-fatal results of device failure. 
These benefits may be somewhat offset by the loss of the original 
therapeutic benefit provided by the device for patients who do not 
experience an adverse event.

F. Annual Costs and Benefits of the Regulation

    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.

G. Small Business Analysis/Regulatory Flexibility Analysis

    We believe that it is possible that the regulation will have a 
significant impact on a substantial number of small entities and have 
conducted a 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 requested that 
such entities review the rule and submit comments to us, and we have 
responded to these comments in section II.G of this document.
1. Description of Impact
    The objective of the regulation 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 events that could endanger 
public health. Our statutory authority for the rulemaking is discussed 
earlier in this preamble.
    This regulation affects manufacturers 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 supporting and are used outside 
a device user facility regardless of size, because PS will likely be 
required for some of their currently marketed and new devices. There 
are four industries\2\ affected by the

[[Page 38885]]

regulations: Surgical and Medical Instrument Manufacturing (NAIC 
339112), Dental Equipment and Supplies Manufacturing (NAIC 339114), 
Ophthalmic Goods Manufacturing (NAIC 339115), and Surgical Appliances 
and Supplies Manufacturing (NAIC 339113). Manufacturers in these 
industries are highly specialized, with between 93 and 98 percent of 
establishment sales within the affected industries. In addition, 
between 93 and 98 percent of medical, dental, and ophthalmic products 
are supplied by establishments within these industries.
---------------------------------------------------------------------------

    \2\The categories that we use in the Small Business and 
Regulatory Flexibility analyses are those used by the Census Bureau. 
Since the publication of the proposed rule, the Census Bureau has 
modified their categorization and coding scheme. These changes did 
not affect the types of manufacturers that we anticipate may be 
subject to PS, nor did they affect our conclusion that the majority 
of medical device manufacturers would be considered small entities.
---------------------------------------------------------------------------

    For each of these four industries, the Small Business 
Administration classifies as small any entity with 500 or fewer 
employees. Under this definition, 95 percent of the manufacturers 
within these industry groups are small businesses, and account for 
approximately 65 percent of the value of the shipments for the affected 
industries. Over 68 percent of the establishments in these four 
industries have 20 or fewer employees and the companies have an average 
of 1.08 establishments per company. The average company in these 
industries has about $7.5 million in annual revenues and about 60 
employees. Consequently, there is a high likelihood that manufacturers 
of some of the devices that would be subject to this regulation will be 
small entities.
    Based on the cost assumptions described above, any company 
conducting PS with primary data collection would expend 4.3 percent of 
annual revenues. Secondary data collection would cost an average 
company 2.2 percent of annual revenues. (Literature searches are not 
expected to impose significant costs.) Since 60 percent of the expected 
PS orders would require significant outlays, we believe that a 
substantial number of small entities would be significantly affected.
    Any PS effort would require professional resources. Primary data 
collection would require clinical researchers, data analysts, and legal 
staff. Other PS would require data analysts and support. Manufacturers 
of devices likely to be subject to PS orders would be familiar with 
data analysis and the clinical community because of their pre- and 
postmarket experience. They would therefore have access to the 
professional skills needed to conduct PS.
2. Analysis of Alternatives
    We examined and rejected the following alternatives to the 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) exempting 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 regulation 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 
regulation. In addition, since all class II devices are marketed 
through premarket notification procedures, postapproval studies are not 
an option for those devices. We rejected this alternative.
Alternative 4
    We rejected the alternative of relying on an enhanced MDR system. 
While MDRs are extremely important in assessing public health, it is a 
passive system of data collection in that it relies on reports from 
concerned professionals who become aware of device problems to 
manufacturers or their representatives. While manufacturers must report 
these adverse events, they are not required to actively go out and look 
for problems with their devices under the MDR provisions. Often MDR 
reports are not specific enough to address discrete issues. We believe 
that the public health objectives are clearly met by requiring more 
active data collection and analysis by the responsible manufacturers of 
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 requirements. We recognize that an order to conduct 
surveillance would likely cause a significant impact on a small entity. 
However, unless and until a PS order affecting a device that it 
manufactures is issued, this regulation creates no impact on a 
manufacturer regardless of size. Section 522 of the act, which this 
regulation implements, is intended to protect the health by authorizing 
PS orders to be issued for devices meeting statutory criteria when 
there is a question indicating a potential public health risk, 
regardless of who manufactures the device. Because devices manufactured 
by small entities could pose a public health risk meeting the statutory 
criteria for imposing PS as easily as could devices manufactured by 
large entities, and because FDA cannot predict who will manufacture 
devices meriting PS in the future, exempting all small manufacturers 
from this rule is not consistent with the objectives of the underlying 
statute. This is particularly clear because, as stated earlier, 95 
percent of the manufacturers in the affected industries are considered 
small business entities, and these small entities account for 
approximately 65 percent of the aggregate value of shipments in their 
industries. Consequently, exempting small entities from the rule could 
reduce the effectiveness of the rule by 65 percent or more.
3. Ensuring Small Entity Participation in Rulemaking

[[Page 38886]]

    We believe it is possible that this rulemaking could have a 
significant impact on a substantial number of small entities. The 
impact would include the costs of conducting PS for specific devices. 
The proposed regulation was available on our Web site (www.fda.gov), 
and we announced the availability of the proposed regulation, 
requesting comments, at several meetings at which members of the 
affected industries were present. We solicited comments from affected 
entities to ensure this impact was analyzed. We received one comment 
questioning the identification of the affected entities impacted by the 
rule (comment 25 of this document). As noted in response to that 
comment, these categories were used to estimate the proportion of 
medical device manufacturers that would be designated ``small 
businesses.'' Although the percentages varied slightly, the business 
size for all of the categories cited was overwhelmingly ``small.'' 
Therefore, the economic analysis assumed that the majority of 
manufacturers affected by this regulation would be considered ``small 
businesses.''

H. Conclusions

    We have examined the impacts of the regulation implementing PS for 
specific medical devices. Based on these estimates, the average annual 
quantified benefits ($15.7) million exceed the average annualized costs 
of conducting surveillance ($5.2 million). In addition, we expect that 
between 3 and 4 statistical fatalities will be avoided each year 
because of this regulation.
    We have examined the impacts of the regulation and have concluded 
that it is likely that a substantial number of small entities will be 
significantly impacted.

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

    This final rule contains information collection requirements that 
are subject to review by the Office of Management and Budget (OMB) 
under the PRA of 1995 (44 U.S.C. chapter 3501-3520). The title, 
description, and respondent description of the information collection 
requirements are shown below with an estimate of the annual reporting 
and recordkeeping burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
Title: Postmarket Surveillance Recordkeeping and Reporting Requirements 
for Manufacturers of Class II and Class III Devices\3\
---------------------------------------------------------------------------

    \3\FDA has changed the title from the PRA section of the 
proposed rule to more accurately describe the nature of the 
information collection provisions of the rule.
---------------------------------------------------------------------------

Description: This final rule implements the PS provisions of section 
522(a) of the act, as added to the act by SMDA and amended by the FDAMA 
(Public Law 105-115). The reporting and recordkeeping provisions of the 
rule implement the collection of useful data or other information 
necessary to protect the public health and to provide safety and 
effectiveness information about the device. The final rule applies to 
manufacturers of class II and class III devices who have received an 
order to conduct PS of a particular device. These device manufacturers 
must develop and submit for FDA approval a plan for PS designed to 
answer the question(s) posed in FDA's order. As they conduct this 
surveillance, manufacturers must maintain records of the surveillance 
and submit interim and final reports to FDA.
Description of Respondents: Manufacturers of class II or class III 
devices that have received an order to conduct PS from FDA.
    FDA received several comments on the collection of information 
described in the proposed rule. Two comments noted that the collection 
of information is unnecessary for devices manufactured for export only 
and for minor changes to an approved PS plan. We agree, and have 
modified the regulation accordingly, as noted under ``Postmarket 
Surveillance Plan'' (devices for export only) and ``FDA Review and 
Action'' (changes to approved PS plan).
    Two comments contained suggestions to enhance the quality, utility, 
and clarity of information collected under the PS rule. The first 
suggestion, that we be required to meet with the affected 
manufacturer(s) prior to issuing a PS order, is discussed in section 
II.C of this document, ``Notification.'' The second suggestion, that we 
provide more guidance as to what we expect in a PS plan and the 
criteria that will be used in evaluating the plan, has been addressed 
in section II.E of this document, ``FDA Review and Action.''
    The FDA has had limited experience with PS under SMDA, and FDAMA 
significantly modified the provisions of section 522 of the act. Based 
on current staffing and resources, we anticipate that we will issue PS 
orders for six generic devices each year, each manufactured by an 
average of five manufacturers. Therefore, 3 years after implementation, 
we would expect that the recordkeeping requirements would apply to a 
maximum of 90 manufacturers (30 added each year) and 270 investigators 
(3 per surveillance plan). After 3 years, we would expect these numbers 
to remain level as the surveillance plans conducted under the earliest 
orders reach completion and new orders are issued. Each manufacturer 
will be required to submit a PS plan (Secs. 822.9 and 822.10) and 
interim and final reports on the progress of the surveillance 
(Sec. 822.38). We anticipate that a small number of respondents will 
propose changes to their PS plans (Sec. 822.21), request a waiver of a 
specific requirement of this regulation (Sec. 822.29), or request 
exemption from the requirement to conduct PS of their device 
(Sec. 822.30). Our experience has shown that a few respondents will go 
out of business (Sec. 822.27) or cease marketing the device subject to 
PS (Sec. 822.28) each year. In addition, manufacturers must certify 
transfer of records when a sponsor or investigator changes 
(Sec. 822.34). We anticipate that this will apply to a small number of 
respondents. We expect that at least some of the manufacturers will be 
able to satisfy the PS requirement using information or data they 
already have. 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. These 
estimates are based on our knowledge and experience with limited 
implementation of section 522 under SMDA.
    FDA estimates the burden for this collection of information as 
follows:

[[Page 38887]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Annual Frequency      Total Annual
                   21 CFR Section                     No. of Respondents     per Response          Responses      Hours per Response      Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.9 and 822.10                                             30                   1                  30                 120               3,600
822.21                                                        4                   1                   4                  40                 160
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                                                                                                                                    18,708
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                          No. of        Annual Frequency of    Total Annual      Hours per
   21 CFR Section      Recordkeepers       Recordkeeping          Records         Record          Total Hours
----------------------------------------------------------------------------------------------------------------
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.

    As explained in section II.B, General Comments, under comment 16 of 
this preamble, the final version of Sec. 822.21 differs from the 
proposed version of the rule. These changes do not materially alter the 
average burden of that rule and thus do not substantially modify the 
collection of information from the proposed version of that section (5 
CFR 1320.5(g) and 1320.11(h)(2)). Requirements for manufacturers 
proposing major changes to approved plans remain substantially 
unchanged from those posed under the proposed rule, requiring an 
estimated 40 hours per response, but FDA has revised the burden chart 
to reflect the prediction that four manufacturers will annually propose 
such major changes, rather than the seven respondents predicted under 
the proposed rule. Under the final rule, manufacturers making minor 
changes must report their changes in the interim report required under 
Sec. 822.38, and the burden of this requirement is reported and 
approved under that section.
    Section 822.26 does 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).)
    Individuals and organizations may submit comments on these burden 
estimates or on any other aspect of these information collection 
provisions, including suggestions for reducing the burden, and should 
direct them to the Office of Surveillance and Biometrics (HFZ-510), 
Attn: David L. Daly, 1350 Piccard Dr., Rockville, MD 20850.
    The information collection requirements in this final rule have 
been approved under OMB control number 0910-0449. This approval expires 
November 30, 2003. An agency may not conduct or sponsor, and a person 
is not required to respond to, a collection of information unless it 
displays a currently valid OMB control number.

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, 21 CFR part 
822 is 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--Postmarket 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 your decision?
822.19 What kinds of decisions may you 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

[[Page 38888]]

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 in the plan changes?
822.35 Can you inspect my manufacturing site or other sites involved in 
my postmarket surveillance plan?
822.36 Can you inspect and copy the records related to my postmarket 
surveillance plan?
822.37 Under what circumstances would you inspect records identifying 
subjects?
822.38 What reports must I submit to you?

    Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

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 class II and class III devices that meet any 
of the following criteria:
    (a) Failure of the device would be reasonably likely to have 
serious adverse health consequences;
    (b) The device is intended to be implanted in the human body for 
more than 1 year; or
    (c) The device is intended to be used outside a user facility to 
support or sustain life. If you fail to comply with requirements that 
we order under section 522 of the act and this part, your device is 
considered misbranded under section 502(t)(3) 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?

    The purpose of this part is to implement our postmarket 
surveillance authority to maximize the likelihood that postmarket 
surveillance plans will result in the collection of useful data. These 
data can reveal unforeseen adverse events, the actual rate of 
anticipated adverse events, or 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 our 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.
    (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 us 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 a device, 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 either is 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;

[[Page 38889]]

    (b) The device is intended to be implanted in the human body for 
more than 1 year; or
    (c) The device is intended to be used to support or sustain life 
and to be 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. 
Before we send the order, or as part of the order, we may require that 
you submit information about your device that will allow us better to 
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?

    (a) If you do not agree with our decision to order postmarket 
surveillance for a particular device, you may request review of our 
decision by:
    (1) Requesting a meeting with the Director, Office of Surveillance 
and Biometrics, who generally issues the order for postmarket 
surveillance;
    (2) Seeking internal review of the order under Sec. 10.75 of this 
chapter;
    (3) Requesting an informal hearing under part 16 of this chapter; 
or
    (4) Requesting review by the Medical Devices Dispute Resolution 
Panel of the Medical Devices Advisory Committee.
    (b) You may obtain guidance documents that discuss these mechanisms 
from the Center for Devices and Radiological Health's (CDRH's) Web site 
(www.fda.gov/cdrh/resolvingdisputes), and from the CDRH Facts-on-Demand 
system (800-899-0381 or 301-827-0111).

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, send 
three copies of your submission to the 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 acknowledgment letter identifying the unique document 
number assigned to your submission. You must 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
    (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) The investigator agreement, if applicable;
    (g) Sources of data, e.g., hospital records;
    (h) The data collection plan and forms;
    (i) The consent document, if applicable;
    (j) Institutional Review Board information, if applicable;
    (k) The patient followup plan, if applicable;
    (l) The procedures for monitoring conduct and progress of the 
surveillance;
    (m) An estimate of the duration of surveillance;
    (n) All data analyses and statistical tests planned;
    (o) 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 
consider what, if any, patient protection measures should be 
incorporated into your plan. 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?

    Guidance documents that discuss our current thinking on preparing a 
postmarket surveillance submission and designing a postmarket 
surveillance plan are available on the Center for Devices and 
Radiological Health's Web site and from the Center for Devices and 
Radiological Health, Office of Surveillance and Biometrics (HFZ-510), 
1350 Piccard Dr., Rockville, MD 20850. Guidance documents represent our 
current interpretation of, or policy on, a regulatory issue. They do 
not establish legally enforceable rights or responsibilities and do not 
legally bind you or FDA. You may choose to use an approach other than 
the one set forth in a guidance document, as long as your alternative 
approach complies with the relevant statutes (laws) and regulations. If 
you wish, we will meet with you to discuss whether an alternative 
approach you are considering will satisfy the requirements of the act 
and regulations.

[[Page 38890]]

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 the Medical Devices Dispute Resolution Panel to 
resolve the matter. You may obtain guidance regarding dispute 
resolution procedures from the Center for Devices and Radiological 
Health's (CDRH) Web site (www.fda.gov/cdrh/resolvingdisputes/ombudsman.html) and from the CDRH Facts-on-Demand system (800-899-0381 
or 301-827-0111, document number 1121). The 36-month period refers to 
the surveillance period, not the length of time from the issuance of 
the order.

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 your 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 you make?

----------------------------------------------------------------------------------------------------------------
               If your plan:                      Then we will send you:                 And you must:
----------------------------------------------------------------------------------------------------------------
(a) Should result in the collection of      An approval order, identifying     Conduct postmarket surveillance
 useful data that will address the           any specific requirements          of your device in accordance
 postmarket surveillance question            related to your postmarket         with the approved plan
                                             surveillance
(b) Should result in the collection of      An approvable letter identifying   Revise your postmarket
 useful data that will address the           the specific revisions or          surveillance submission to
 postmarket surveillance question after      information that must be           address the concerns in the
 specific revisions are made or specific     submitted before your plan can     approvable letter and submit it
 information is provided                     be approved                        to us within the specified
                                                                                timeframe. We will determine the
                                                                                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    Revise your postmarket
 specified in this part                      and identifying the reasons for    surveillance submission and
                                             disapproval                        submit it to us 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    Revise your postmarket
 collection of useful data that will         and identifying the reasons for    surveillance submission and
 address the postmarket surveillance         disapproval                        submit it to us within the
 question                                                                       specified timeframe. We will
                                                                                determine the timeframe case-by-
                                                                                case, based on the types of
                                                                                revisions or information that
                                                                                you must submit
----------------------------------------------------------------------------------------------------------------

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)(C) 
of the act, and your device would be misbranded under section 502(t)(3) 
of the act. We have the authority to initiate actions against products 
that are adulterated or misbranded, and against persons who commit 
prohibited acts. Adulterated or misbranded devices can be seized. 
Persons who commit prohibited acts can be enjoined from committing such 
acts, required to pay civil money penalties, or prosecuted.


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 receive our approval in writing before making changes in 
your plan that will affect the nature or validity of the data collected 
in accordance with the plan. To obtain our approval, you must submit 
three copies of the request to make the proposed change and revised 
postmarket surveillance plan to the applicable address listed in 
Sec. 822.8. You may reference information already submitted in 
accordance with Sec. 822.14. In your cover letter, you must identify 
your submission as a supplement and cite the unique document number 
that we assigned in our acknowledgment letter for your original 
submission, specifically identify the changes to the plan, and identify 
the reasons and justification for making the changes. You must report 
changes in your plan that will not affect the nature or validity of the 
data collected in accordance with the plan in the next interim report 
required by your approval order.


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

    (a) If you disagree with us about the content of your plan or if we 
disapprove your plan, or if you believe there is a less burdensome 
approach that will answer the surveillance question, you may request 
review of our decision by:

[[Page 38891]]

    (1) Requesting a meeting with the Director, Office of Surveillance 
and Biometrics, Center for Devices and Radiological Health (CDRH), who 
generally issues the order for postmarket surveillance;
    (2) Seeking internal review of the order under Sec. 10.75 of this 
chapter;
    (3) Requesting an informal hearing under part 16 of this chapter; 
or
    (4) Requesting review by the Medical Devices Dispute Resolution 
Panel of the Medical Devices Advisory Committee.
    (b) You may obtain guidance documents that discuss these mechanisms 
from the CDRH Web site and from the CDRH Facts-on-Demand System (800-
899-0381 or 301-827-0111).


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 once 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 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 us 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 and 
the new owner 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. 822.8.


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. 822.8.

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, if your 
surveillance plan uses investigators, stating the commitment to conduct 
the surveillance in accordance with the 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, such as copies of signed consent documents, 
evidence of Institutional Review Board review and approval, etc.


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

    Your investigator must keep copies of:
    (a) All correspondence between investigators, FDA, the 
manufacturer, and the designated person, 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 at that site 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 the records?

    You, the designated person, and your investigators must keep all 
records for a period of 2 years after we have accepted

[[Page 38892]]

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 working 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 you 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 involved in your postmarket 
surveillance, such as 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 you 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 regulation. You must 
be able to produce records and information required by this regulation 
that are in the possession of others under contract with you to conduct 
the postmarket surveillance. Those who have signed agreements or are 
under contract with you must also 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 you 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. We are 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 you?

    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: December 26, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-14100 Filed 6-5-02; 8:45 am]
BILLING CODE 4160-01-S