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[Federal Register: April 1, 1998 (Volume 63, Number 62)]
[Notices]
[Page 15851-15852]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01ap98-72]
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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availability of the draft guidance entitled ``Guidance to Industry and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Previously Submitted Materials, and Priority Review'' (the CDRH draft
guidance).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document is being issued as a draft guidance.
DATES: Written comments on the CDRH draft guidance must be received by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ADDRESSES: Submit written requests for single copies of the CDRH draft
guidance entitled ``Guidance to Industry and CDRH for PMAs and PMA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comments on the CDRH draft guidance to the Dockets Management Branch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
Updated 4/1/1998
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