[Federal Register Volume 63, Number 74 (Friday, April 17, 1998)]
[Proposed Rules]
[Pages 19196-19200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9638]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 63, No. 74 / Friday, April 17, 1998 / 
Proposed Rules  

[[Page 19196]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. 98N-0171]


Medical Devices; Humanitarian Use of Devices; Companion to Direct 
Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
certain regulations governing humanitarian use devices. This proposed 
rule is a companion document to the direct final rule published 
elsewhere in this issue of the Federal Register. The amendments are 
being made to implement provisions of the Federal Food, Drug, and 
Cosmetic Act (the act) as amended by the Food and Drug Administration 
Modernization Act of 1997 (FDAMA). This companion proposed rule is 
being issued under FDAMA and the act as amended.

DATES: Comments must be received on or before July 1, 1998. Comments on 
the information collection requirements must be received on or before 
June 16, 1998.
ADDRESSES: Submit written comments on the companion proposed rule to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Joanne R. Less, Center for Devices and 
Radiological Health (HFZ-403), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20857.

SUPPLEMENTARY INFORMATION:

I. Background

    This proposed rule is a companion to the direct final rule 
published in the final rules section of this issue of the Federal 
Register. The direct final rule and this companion proposed rule are 
substantively identical. FDA is publishing the direct final rule 
because the rule contains noncontroversial changes, and FDA anticipates 
that it will receive no significant adverse comments. A detailed 
discussion of this rule is set forth in the preamble of the direct 
final rule. If no significant comment is received in response to the 
direct final rule, no further action will be taken related to this 
proposed rule. Instead, FDA will publish a confirmation notice within 
30 days after the comment period ends confirming that the direct final 
rule will go into effect on August 31, 1998. Additional information 
about FDA's direct final rulemaking procedures is set forth in a 
guidance published in the Federal Register of November 21, 1997 (62 FR 
62466).
    If FDA receives any significant adverse comment regarding this 
rule, FDA will publish a document withdrawing the direct final rule 
within 30 days after the comment period ends and will proceed to 
respond to all of the comments under this companion proposed rule using 
usual notice-and-comment procedures. The comment period for this 
companion proposed rule runs concurrently with the direct final rules's 
comment period. Any comments received under this companion proposed 
rule will also be considered as comments regarding the direct final 
rule.
    A significant adverse comment is defined as a comment that explains 
why the rule would be inappropriate, including challenges to the rule's 
underlying premise or approach, or would be ineffective or unacceptable 
without a change. In determining whether a significant adverse comment 
is sufficient to terminate a direct final rulemaking, FDA will consider 
whether the comment raises an issue serious enough to warrant a 
substantive response in a notice-and-comment process. Comments that are 
frivolous, insubstantial, or outside the scope of the rule will not be 
considered adverse under this procedure. For example, a comment 
recommending a rule change in addition to the rule will not be 
considered a significant adverse comment, unless the comment states why 
the rule would be ineffective without the additional change. In 
addition, if a significant adverse comment applies to part of a rule 
and that part can be severed from the remainder of the rule, FDA may 
adopt as final those parts of the rule that are not the subject of a 
significant adverse comment.
    This action is part of FDA's continuing effort to achieve the 
objectives of the President's ``Reinventing Government'' initiative, 
and it is intended to reduce the burden of unnecessary regulations on 
medical devices without diminishing the protection of public health.
    Section 520(m) of the act (21 U.S.C. 360j(m)) was added by the Safe 
Medical Devices Act of 1990 (Pub. L. 101-629). Section 520(m) creates 
an incentive for the development of humanitarian use devices (HUD) for 
use in the treatment or diagnosis of diseases or conditions affecting a 
small number of individuals. Section 520(m) of the act authorizes FDA, 
by regulation, to exempt a HUD from the effectiveness requirements of 
sections 514 and 515 of the act (21 U.S.C. 360d and 360e) (i.e., 
``reasonable assurance that the device is effective'') provided that: 
(1) The device is to be used to treat or diagnose a disease or 
condition that affects fewer than 4,000 individuals in the United 
States; (2) the device would not be available to a person with such a 
disease or condition unless the exemption is granted; (3) no comparable 
device (other than a device that has been granted such an exemption) is 
available to treat or diagnose the disease or condition; and (4) the 
device will not expose patients to an unreasonable or significant risk 
of illness or injury, and the probable benefit to health from using the 
device outweighs the risk of injury or illness from its use, taking 
into account the probable risks and benefits of currently available 
devices to alternative forms or treatments.
    In the Federal Register of June 26, 1996 (61 FR 33232), FDA 
published a final rule prescribing the procedures for submitting 
humanitarian device exemption (HDE) applications, amendments, and 
supplements; procedures for obtaining an extension of the exemption; 
and the criteria for FDA review and approval of HDE's. This rule 
amended part 814 (21 CFR part 814) of FDA's regulations.
    On November 21, 1997, the President signed FDAMA into law. Section 
203 of

[[Page 19197]]

FDAMA made the following changes to section 520(m) of the act:
    (1) FDAMA added a new provision to section 520(m) of the act that 
requires FDA to issue an order approving or denying an HDE within 75 
days after receiving the application.
    (2) FDAMA provided for an exemption from the requirement that a HUD 
may not be used without approval from an institutional review board 
(IRB) for cases in which a physician determines in an emergency 
situation that approval cannot be obtained in time to prevent serious 
harm or death to a patient. In such cases, the physician must, after 
use of the device, notify the chairperson of the IRB. This notification 
must include the name of the patient, the date on which the device was 
used, and the reason for the use.
    (3) FDAMA eliminated the requirement that the sponsor of an HDE 
obtain approval for continued use after 18 months. Instead, FDA may 
require a sponsor to demonstrate continued compliance with the 
requirements of section 520(m) of the act, if FDA believes that such a 
demonstration is necessary to protect the public health, or if FDA has 
reason to believe that the criteria for exemption are no longer met.
    (4) FDAMA added a provision to section 520(m) of the act that FDA 
may withdraw an HDE approval only after providing notice and an 
opportunity for an informal hearing.
    (5) FDAMA eliminated the ``sunset'' provision in section 520(m) of 
the act under which new approvals of HDE's would not have been 
permitted 5 years after the effective date of the rule originally 
implementing section 520(m).
    FDA is issuing this companion proposed rule to amend the existing 
regulations to conform to revised section 520(m) of the act. For a 
discussion of the specific provisions of the regulation, see the 
preamble to the direct final rule published elsewhere in this issue of 
the Federal Register.

II. Environmental Impact

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

III. Analysis of Impacts

    FDA has examined the impact of this companion proposed rule under 
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612) (as amended by subtitle D of the Small Business Regulatory 
Fairness Act of 1996 (Pub. L. 104-121)), and the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety and other advantages; 
distributive impacts; and equity). The agency believes that this 
proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The rule codifies applicable statutory requirements 
imposed by FDAMA. Because the companion proposed rule allows physicians 
more flexibility without compromising the public health and reduces the 
requirements imposed on sponsors, it may permit more small competitors 
to enter the marketplace. The agency, therefore, certifies that this 
proposed rule if issued, will not have a significant economic impact on 
a substantial number of small entities. In addition, this proposed rule 
will not impose costs of $100 million or more in either the private 
sector or State, local, and tribal governments in the aggregate, and 
therefore a summary statement of analysis under section 202(a) of the 
Unfunded Mandates Reform Act of 1995 is not required.

IV. Paperwork Reduction Act of 1995

    This companion proposed rule contains information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3501-3520). The title, description, and respondent description 
of the information collection provisions are shown below with an 
estimate of the annual reporting and recordkeeping burden. Included in 
the estimate is the time for reviewing the instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing each collection of information.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title:  Amendments to Humanitarian Use Device Requirements.
    Description: Section 520(m) of the act was created as an incentive 
for the development of HUD's for use in the treatment or diagnosis of 
diseases or conditions affecting fewer than 4,000 individuals in the 
United States. FDA is issuing this rule to propose amending the 
existing regulations governing HUD's found in part 814, to conform to 
the amendments made by FDAMA to section 520(m) of the act.
    Section 814.124(a) would allow physicians in emergency situations 
to administer a HUD prior to obtaining IRB approval. In such 
situations, the physician would be required to provide written 
notification, including the identification of the patient involved, the 
date of use, and the reason for use, to the IRB within 5 days after 
emergency use. FDA anticipates that five physicians will use HUD's in 
emergency situations before obtaining approval from an IRB. FDA 
estimates that notifications under this section will take an average of 
1 hour per response.
    FDA is proposing to amend Sec. 814.126(b)(1) to delete the 
requirement for a final report and to include an annual reporting 
requirement for HDE holders that will permit the agency to obtain 
sufficient information for it to determine whether there is reason to 
question the continued exemption of the device from the act's 
effectiveness requirements. FDA estimates that 15 HDE holders will 
submit annual reports. FDA believes that much of the information will 
already be in the HDE holder's possession, and the agency estimates 
that reports will take an average of 120 hours per response.
    In addition to the changes required by FDAMA, FDA is proposing to 
amend Sec. 814.104(b)(5) to allow a sponsor who is charging more than 
$250 per HUD to submit, in lieu of a report by an independent certified 
public accountant (CPA), an attestation by a responsible individual of 
the organization, verifying that the amount charged does not exceed the 
device's cost of research, development, fabrication, and distribution. 
In addition, the proposed

[[Page 19198]]

amendments to Sec. 814.104(b)(5) would waive the requirement for 
submission of any CPA report or attestation for HUD's for which an HDE 
applicant is charging $250 or less. FDA anticipates, based on past 
experience, that 7 of the anticipated 15 HDE holders per year will 
charge less than $250 per HUD, and thus be exempt from the 
Sec. 814.104(b)(5) requirement altogether. For the remaining eight HDE 
holders, FDA anticipates that all will submit attestations in lieu of 
CPA reports, and estimates that these submissions will require 2 hours 
to complete.
    Section 814.126(b)(2) would modify the current recordkeeping 
requirement for HDE holders to require that HDE holders retain records 
indefinitely instead of only for the duration of the period for which 
the HUD is approved for marketing. FDA believes that this change will 
not affect the total time required to maintain the records.
    Description of Respondents: Business or other for profit 
organizations.
    FDA estimates the burden for this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden                                  
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
814.104(b)(5)                           8               1               8               2              16       
814.124(a)                              5               1               5               1               5       
814.126(b)(1)                          15               1              15             120           1,800       
Total                                                                                               1,821       
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                                Table 2.--Estimated Annual Recordkeeping Burden1                                
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
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814.126(b)(2)                          15               1              15               2              30       
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\1\There are no operating and maintenance costs or capital costs associated with this information collection.   

    For consistency with the direct final rule to which this proposed 
rule is a companion, FDA is following the PRA comment procedures for 
direct final rules in this proposed rule. As provided in 5 CFR 
1320.5(c)(1), collections of information in a direct final rule are 
subject to the procedures set forth in 5 CFR 1320.10. Interested 
persons and organizations may submit comments on the information 
collection provisions of this proposed rule by June 16, 1998, to the 
Dockets Management Branch (address above).
    At the close of the 60-day comment period, FDA will review the 
comments received, revise the information collection provisions as 
necessary, and submit the provisions to OMB for review. FDA will 
publish a notice in the Federal Register when the information 
collection provisions are submitted to OMB, and an opportunity for 
public comment to OMB will be provided at that time. Prior to the 
effective date of the direct final rule, FDA will publish a notice in 
the Federal Register of OMB's decision to approve, modify, or 
disapprove the information collection provisions. 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.

V. Submission of Comments

    Interested persons may, on or before July 1, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. This comment period runs concurrently with the comment 
period for the direct final rule. Two copies of any comments are to be 
submitted except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday. All comments received 
will be considered as comments regarding the direct final rule and this 
proposed rule. In the event, the direct final rule is withdrawn, all 
comments received will be considered comments on this proposed rule.

List of Subjects 21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, 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 
814 is amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

    1. The authority citation for 21 CFR part 814 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 
373, 374, 375, 379, 379e, 381.

    2. Section 814.100 is amended by revising paragraphs (a)(2) and (d) 
and by adding new paragraph (e) to read as follows:


Sec. 814.100   Purpose and scope.

    (a) * * *
    (2) Marketing approval for the HUD notwithstanding the absence of 
reasonable assurance of effectiveness that would otherwise be required 
under sections 514 and 515 of the act.
* * * * *
    (d) A person granted an exemption under section 520(m) of the act 
shall submit an annual report as described in Sec. 814.126 (b).
    (e) FDA may suspend or withdraw approval of an HDE after providing 
notice and an opportunity for an informal hearing.
    3. Section 814.104 is amended by removing paragraph (b) and 
redesignating paragraphs (c) through (e) as paragraphs (b) through (d), 
by revising redesignated paragraph (b)(5) and the first sentence in 
redesignated paragraph (c), and by revising redesignated paragraph (d) 
to read as follows:


Sec. 814.104  Original applications.

* * * * *
    (b) * * *

[[Page 19199]]

    (5) The amount to be charged for the device and, if the amount is 
more than $250.00, a report by an independent certified public 
accountant, made in accordance with the Statement on Standards for 
Attestation established by the American Institute of Certified Public 
Accountants, or in lieu of such a report, an attestation by a 
responsible individual of the organization, verifying that the amount 
charged does not exceed the costs of the device's research, 
development, fabrication, and distribution. If the amount charged is 
$250.00 or less, the above requirement will be waived.
    (c) Omission of information. If the applicant believes that certain 
information required under paragraph (b) of this section is not 
applicable to the device that is the subject of the HDE, and omits any 
such information from its HDE, the applicant shall submit a statement 
that identifies and justifies the omission. * * *
    (d) Address for submissions and correspondence. Copies of all 
original HDE's, amendments and supplements, as well as any 
correspondence relating to an HDE, shall be sent or delivered to the 
Document Mail Center (HFZ-401), Office of Device Evaluation, Center for 
Devices and Radiological Health, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850.
    4. Section 814.106 is revised to read as follows:


Sec. 814.106   HDE amendments and resubmitted HDE's.

    An HDE or HDE supplement may be amended or resubmitted upon an 
applicant's own initiative, or at the request of FDA, for the same 
reasons and in the same manner as prescribed for PMA's in Sec. 814.37, 
except that the timeframes set forth in Sec. 814.37(c)(1) and (d) do 
not apply. If FDA requests an HDE applicant to submit an HDE amendment, 
and a written response to FDA's request is not received within 75 days 
of the date of the request, FDA will consider the pending HDE or HDE 
supplement to have been withdrawn voluntarily by the applicant. 
Furthermore, if the HDE applicant, on its own initiative or at FDA's 
request, submits a major amendment as described in Sec. 814.37(c)(1), 
the review period may be extended up to 75 days.
    5. Section 814.108 is revised to read as follows:


Sec. 814.108  Supplemental applications.

    After FDA approval of an original HDE, an applicant shall submit 
supplements in accordance with the requirements for PMA's under 
Sec. 814.39, except that a request for a new indication for use of a 
HUD shall comply with requirements set forth in Sec. 814.110. The 
timeframes for review of and FDA action on an HDE supplement are the 
same as those provided in Sec. 814.114 for an HDE.
    6. Section 814.112 is amended by revising the introductory text of 
paragraph (a) and by revising paragraph (b) to read as follows:


Sec. 814.112  Filing an HDE.

    (a) The filing of an HDE means that FDA has made a threshold 
determination that the application is sufficiently complete to permit 
substantive review. Within 30 days from the date an HDE is received by 
FDA, the agency will notify the applicant whether the application has 
been filed. FDA may refuse to file an HDE if any of the following 
applies:
* * * * *
    (b) The provisions contained in Sec. 814.42 (b), (c), and (d) 
regarding notification of filing decisions, filing dates, the start of 
the 75-day review period, and applicant's options in response to FDA 
refuse to file decisions shall apply to HDE's.
    7. Section 814.114 is revised to read as follows:


Sec. 814.114  Timeframes for reviewing an HDE.

    Within 75 days after receipt of an HDE that is accepted for filing 
and to which the applicant does not submit a major amendment, FDA will 
send the applicant an approval order, an approvable letter, a not 
approvable letter (under Sec. 814.116), or an order denying approval 
(under Sec. 814.118).
    8. Section 814.116 is amended by revising the last sentence in 
paragraph (a), adding a sentence to the end of paragraph (a), revising 
the last sentence of paragraph (d), and adding paragraph (e) to read as 
follows:


Sec. 814.116  Procedures for review of an HDE.

    (a) * * * If the HDE is referred to a panel, the agency shall 
follow the procedures set forth under Sec. 814.44, with the exception 
that FDA will complete its review of the HDE and the advisory committee 
report and recommendations within 75 days from receipt of an HDE that 
is accepted for filing under Sec. 814.112 or the date of filing as 
determined under Sec. 814.106, whichever is later. Within the later of 
these two timeframes, FDA will issue an approval order under paragraph 
(b) of this section, an approvable letter under paragraph (c) of this 
section, a not approvable letter under paragraph (d) of this section, 
or an order denying approval of the application under Sec. 814.118(a).
* * * * *
    (d) * * * The applicant may respond to the not approvable letter in 
the same manner as permitted for not approvable letters for PMA's under 
Sec. 814.44(f), with the exception that if a major HDE amendment is 
submitted, the review period may be extended up to 75 days.
    (e) FDA will consider an HDE to have been withdrawn voluntarily if:
    (1) The applicant fails to respond in writing to a written request 
for an amendment within 75 days after the date FDA issues such request;
    (2) The applicant fails to respond in writing to an approvable or 
not approvable letter within 75 days after the date FDA issues such 
letter; or
    (3) The applicant submits a written notice to FDA that the HDE has 
been withdrawn.
    9. Section 814.118 is amended by revising paragraph (e) to read as 
follows:


Sec. 814.118   Denial of approval or withdrawal of approval of an HDE.

* * * * *
    (e) Unless FDA otherwise determines that continued marketing under 
the HDE is inconsistent with the intent of section 520(m) of the act, 
FDA will not withdraw approval of an HDE solely because it is 
subsequently determined that the disease or condition for which the HUD 
is intended affects or is manifested in more than 4,000 people in the 
United States per year.
     10. Section 814.120 and the heading is revised to read as follows:


Sec. 814.120  Temporary suspension of approval of an HDE.

    An HDE or HDE supplement may be temporarily suspended for the same 
reasons and in the same manner as prescribed for PMA's in Sec. 814.47.
     11. Section 814.124 is amended by adding two sentences at the end 
of paragraph (a) to read as follows:


Sec. 814.124  Institutional Review Board requirements.

    (a) * * * If, however, a physician in an emergency situation 
determines that approval from an IRB cannot be obtained in time to 
prevent serious harm or death to a patient, a HUD may be administered 
without prior approval by the IRB located at the facility or by a 
similarly constituted IRB that has agreed to oversee such use. In such 
an emergency situation, the physician shall, within 5 days after the 
use of the device, provide written notification to the chairman of the 
IRB of such use. Such written notification shall include the 
identification of the patient

[[Page 19200]]

involved, the date on which the device was used, and the reason for the 
use.
     12. Section 814.126 is amended by revising the first sentence in 
paragraph (a) and by revising paragraph (b) to read as follows:


Sec. 814.126  Postapproval requirements and reports.

    (a) An HDE approved under this subpart shall be subject to the 
postapproval requirements and reports set forth under subpart E of this 
part, as applicable, with the exception of Sec. 814.82(a)(7). * * *
    (b) In addition to the reports identified in paragraph (a) of this 
section, the holder of an approved HDE shall prepare and submit the 
following complete, accurate, and timely reports:
    (1) Annual report. An HDE applicant is required to submit an annual 
report on the anniversary date of marketing approval. The annual report 
shall include:
    (i) An update of the information required under Sec. 814.102(a) in 
a separately bound volume;
    (ii) An update of the information required under 
Sec. 814.102(c)(2), (c)(3), and (c)(5);
    (iii) The number of devices that have been shipped or sold since 
initial marketing approval under this subpart H and, if the number 
shipped or sold exceeds 4,000, an explanation and estimate of the 
number of devices used per patient. If a single device is used on 
multiple patients, the applicant shall submit an estimate of the number 
of patients treated or diagnosed using the device together with an 
explanation of the basis for the estimate;
    (iv) Information describing the applicant's clinical experience 
with the device since the HDE was initially approved. This information 
shall include safety information that is known or reasonably should be 
known to the applicant, medical device reports made under part 803 of 
this chapter, any data generated from the postmarketing studies, and 
information (whether published or unpublished) that is known or 
reasonably expected to be known by the applicant that may affect an 
evaluation of the safety of the device or that may affect the statement 
of contraindications, warnings, precautions, and adverse reactions in 
the device's labeling; and
    (v) A summary of any changes made to the device in accordance with 
supplements submitted under Sec. 814.108. If information provided in 
annual reports, or any other information in the possession of FDA, 
gives the agency reason to believe that a device raises public health 
concerns or that the criteria for exemption are no longer met, the 
agency may require the HDE holder to submit additional information to 
demonstrate continued compliance with the HDE requirements.
    (2)Other. An HDE holder shall maintain records of the names and 
addresses of the facilities to which the HUD has been shipped, 
correspondence with reviewing IRB's, as well as any other information 
requested by a reviewing IRB or FDA.

    Dated: March 31, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-9638 Filed 4-16-98; 8:45 am]
BILLING CODE 4160-01-F