[Federal Register Volume 63, Number 62 (Wednesday, April 1, 1998)]
[Notices]
[Pages 15851-15852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8568]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0188]


Guidance to Industry and CDRH for PMAs and PMA Supplements: Use 
of Published Literature, Use of Previously Submitted Materials, and 
Priority Review; Draft; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Guidance to Industry and 
CDRH for PMAs and PMA Supplements: Use of Published Literature, Use of 
Previously Submitted Materials, and Priority Review'' (the CDRH draft 
guidance). The FDA Modernization Act of 1997 (FDAMA) requires the 
agency to issue final guidance to clarify circumstances in which 
published matter may be the basis for approval of a supplemental 
application, specify data requirements that will avoid duplication of 
previously submitted data by recognizing the availability of data 
previously submitted in support of an original application, and define 
supplemental applications that are eligible for priority review. This 
document is being issued as a draft guidance.

DATES: Written comments on the CDRH draft guidance must be received by 
May 1, 1998. Comments will be incorporated in a final guidance that is 
expected to be issued on May 20, 1998.

ADDRESSES: Submit written requests for single copies of the CDRH draft 
guidance entitled ``Guidance to Industry and CDRH for PMAs and PMA 
Supplements: Use of Published Literature, Use of Previously Submitted 
Materials, and Priority Review'' to the Division of Small Manufacturers 
Assistance (HFZ-220), Center for Devices and Radiological Health, Food 
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send 
two self-addressed adhesive labels to assist that office in processing 
your request, or fax your request to 301-443-8818. Submit written 
comments on the CDRH draft guidance to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Comments should be identified with the docket 
number found in brackets in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the CDRH 
draft guidance.

FOR FURTHER INFORMATION CONTACT: Kathy M. Poneleit, Center for Devices 
and Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 403(b) of FDAMA (Pub. L.105-115) provides that no later 
than 180 days after the date of enactment, the Secretary shall issue 
final guidance to clarify the requirements for, and facilitate the 
submission of data to support the approval of supplemental applications 
for articles approved under the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 301 et seq.) or section 351 of the Public Health 
Service Act (42 U.S.C. 262). This provision of FDAMA requires the 
guidance to:

[[Page 15852]]

Clarify circumstances in which published matter may be the basis for 
approval of a supplemental application, specify data requirements that 
will avoid duplication of previously submitted data by recognizing the 
availability of data previously submitted in support of an original 
application, and define supplemental applications that are eligible for 
priority review.
    The Center for Devices and Radiological Health (CDRH) draft 
guidance being issued at this time includes CDRH specific information 
as well as a copy of a draft guidance developed through a joint effort 
between the Center for Drug Evaluation and Research (CDER) and the 
Center for Biologics Evaluation and Research (CBER). The CDER/CBER 
draft guidance discusses the type of clinical evidence to support 
marketing applications for human drugs and biological products. 
Availability of the CDER/CBER draft guidance for comment was announced 
in the Federal Register of March 21, 1997 (62 FR 13650). The CDER/CBER 
draft guidance also explains those Centers' thinking on the use of 
literature to support effectiveness claims for drug and biological 
products.
    Although the CDER/CBER draft guidance document does not address 
device issues directly, CDRH believes that the CDER/CBER draft guidance 
is broadly applicable to premarket approval applications (PMAs) and PMA 
supplements. In particular, the discussion of the use of published data 
to support approvals of supplements to approved products is consistent 
with the policies and regulations CDRH applies to its review of PMA 
supplements. The device industry should note that the examples provided 
in the attached CDER/CBER draft guidance were not developed with 
medical devices in mind and may not all be relevant to the evaluation 
of medical devices. CDRH has already issued guidance similar to the 
CDER/CBER draft guidance with respect to the design and analysis of 
clinical trials intended to support PMAs. That CDRH guidance also 
applies to the design and analysis of clinical trials submitted to 
support PMA supplements and is available on the internet at http://
www.fda.gov/cdrh/manual/pmamanul.pdf.
    CDRH recognizes that there are important differences between 
medical devices and drugs or biologics and differences in the legal 
standards for their approval. The CDRH draft guidance addresses those 
differences and includes explanation of the factors that go into the 
PMA review process. That discussion provides additional guidance on 
CDRH's policies and regulations intended to avoid duplication of 
previously submitted data. It also addresses the use of published 
literature to support PMAs and PMA supplements for marketing approval. 
The CDRH draft guidance refers readers to the Center's guidance on 
priority review and clarifies that it is applicable to determine which 
PMA supplements are eligible for priority review.
    FDA anticipates that the final guidance to be issued by the agency 
on or before May 20, 1998, will apply to all products subject to 
premarket approval requirements, and will reflect and incorporate the 
comments received on the drug, biologic, and device sections.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
Guidance to Industry and CDRH for PMAs and PMA Supplements: Use of 
Published Literature, Use of Previously Submitted Materials, and 
Priority Review. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the applicable statute, 
regulations, or both.
    The agency has adopted Good Guidance Practices (GGPs), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as a Level 1 guidance 
consistent with GGPs. Interested persons may, on or before May 1, 1998, 
submit written comments regarding this draft guidance.

III. Electronic Access

    In order to receive the Guidance to Industry and CDRH for PMAs and 
PMA Supplements: Use of Published Literature, Use of Previously 
Submitted Materials, and Priority Review via your fax machine, call the 
CDRH Facts-On -Demand (FOD) system at 800-899-0381 or 301-827-0111 from 
a touch-tone telephone. At the first voice prompt press 1 to access 
DSMA Facts, at second voice prompt press 2, and then enter the document 
number (620) followed by the pound sign (#). Then follow the remaining 
voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the World Wide Web (WWW). CDRH maintains an entry on the World 
Wide Web for easy access to information text, graphics, and files that 
may be downloaded to a PC with access to the Web. Updated on a regular 
basis, the CDRH home page includes ``Guidance to Industry and CDRH for 
PMAs and PMA Supplements: Use of Published Literature, Recognition of 
Previously Submitted Materials, and Priority Review'', device safety 
alerts, Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturers' assistance, information on video 
conferencing and electronic submissions, mammography matters, and other 
device-oriented information. The CDRH home page may be accessed at 
http://www.fda.gov/cdrh.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 Compatible terminal by dialing 800-222-0185 
(terminal settings are 8/1/N). Once the modem answers, press Enter 
several times and then select menu choice 1:FDA BULLETIN BOARD SERVICE. 
From there follow instructions for logging in, and at the BBS Topics 
Page, arrow down to the FDA home page (do not select the first CDRH 
entry). Then select Medical Devices and Radiological Health. From there 
select Medical Devices and Radiological Health. From there select 
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH FOR GENERAL INFORMATION, or 
arrow down for specific topics.

IV. Comments

    Interested persons may, on or before May 1, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
the CDRH draft guidance. Comments regarding the CDER/CBER draft 
guidance may be submitted, however, such comments must be limited to 
the guidance as it applies to PMAs and PMA supplementals. Such comments 
will be considered when determining whether to amend the draft 
guidance. 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. A copy 
of the CDRH draft guidance and received comments may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: March 27, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-8568 Filed 3-27-98; 3:35 pm]
BILLING CODE 4160-01-F