[Federal Register Volume 63, Number 98 (Thursday, May 21, 1998)]
[Notices]
[Pages 27988-27989]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-13720]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0333]
Guidance for Industry, Supplements to Approved Applications for
Class III Medical Devices: Use of Published Literature, Use of
Previously Submitted Materials, and Priority Review; 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 guidance entitled, ``Guidance for Industry,
Supplements to Approved Applications for Class III Medical Devices: Use
of Published Literature, Use of Previously Submitted Materials, and
Priority Review.'' 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.
DATES: Written comments concerning this guidance may be submitted at
anytime.
ADDRESSes: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled, ``Guidance for Industry,
Supplements to Approved Applications for Class III Medical Devices: 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, 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 ``Guidance for Industry, Supplements to
Approved Applications for Class III Medical Devices: Use of Published
Literature, Use of Previously Submitted Materials, and Priority
Review'' to the contact persons listed below. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
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; or
Jerome A. Donlon, Center for Biologics Evaluation and Research,
1401 Rockville Pike (HFM-200), Rockville, MD 20852-1448, 301-827-3028.
SUPPLEMENTARY INFORMATION:
I. Background
Section 403(b) of FDAMA (Pub. L.105-115) provides that not later
than 180 days after the date of enactment, the Secretary of the
Department of Health and Human Services (FDA by delegation) shall issue
final guidances to clarify the requirements for, and facilitate the
submission of data to support, the approval of supplemental
applications for approved articles 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). The guidances shall:
(1) Clarify circumstances in which published matter may be the
basis for approval of a supplemental application;
(2) 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
(3) Define supplemental applications that are eligible for priority
review.
Section 403(b) of FDAMA is applicable to multiple centers within
FDA. Availability of the draft guidance prepared by the Center for Drug
Evaluation and Research (CDER) and the Center for Biologics Evaluation
and Research (CBER) (CDER/CBER draft guidance) was announced in the
Federal Register of March 21, 1997 (62 FR 13650). The CDER/CBER draft
guidance describes the use of literature and the types of study design
that may support supplemental effectiveness claims for approved drug
and biological products. CDRH issued draft guidance
[[Page 27989]]
on March 20, 1998, that set forth its perspective on the applicability
of the CDER/CBER draft guidance to medical devices.
The agency received two comments on the draft guidance. Both
comments encouraged the agency to issue two separate guidance
documents, one for devices and one for drugs and biologics, rather than
a single guidance document. Also, both comments requested device-
specific examples in the guidance document. One comment requested
additional guidance on other provisions of FDAMA.
Although CDRH initially had expected the final guidance issued in
accordance with 403(b) of the act to be a single agency document that
addressed devices, drugs and biologics, both CDRH and CBER have
decided, in the interest of clarity and consistent with comments
received on the draft guidance, to issue a separate guidance document
for medical devices. This final guidance for medical devices builds
upon the foundation developed in the CDER/CBER draft guidance regarding
the use of published literature, draws upon the existing premarket
approval application (PMA) regulation, and refers to earlier guidance
documents developed by CDRH that describe efforts to avoid duplication
of previously submitted data and that define supplemental applications
that are eligible for priority review. In this final guidance, device
specific examples have replaced the drug examples presented in the
CDER/CBER draft guidance.
This guidance has been revised to account for all class III
products approved as PMA's, including humanitarian device exemption
(HDE) products and product development protocols (PDP's). A Class III
device for which a PDP has been declared completed by FDA is considered
to have an approved PMA Sec. 814.19 (21 CFR 814.19). Supplements to
PDPs, therefore, will be treated as PMA supplements for purposes of
this guidance. This guidance also provides examples of how the use of
published literature may be used in support of a PMA, PDP, or HDE
supplement.
Published literature would most frequently be used to support
supplements for new indications for use of an approved device. In
accordance with Sec. 814.110, an applicant seeking approval for a new
indication for use for an approved humanitarian use device must submit
an original HDE. Therefore, this guidance would apply to HDE
supplements only in unusual circumstances. The agency intends to issue
additional guidance documents on other provisions of FDAMA and will
solicit public comment on those guidances in accordance with FDA's Good
Guidance Practices.
II. Significance of Guidance
This guidance document represents the agency's current thinking on
``Guidance for Industry, Supplements to Approved Applications for Class
III Medical Devices: Use of Published Literature, Use of Previously
Submitted Materials, and Priority Review.'' Both the Center for Devices
and Radiological Health (CDRH) and the Center for Biologics Evaluation
and Research (CBER) have responsibilities for the regulation of medical
devices. This document applies to medical devices regulated by either
CDRH or CBER and reflects the current thinking of both centers on the
subject of this guidance. This document does not apply to medical
devices licensed by CBER. This document is being issued as final
guidance. 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 (GGP's), 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. Written comments may be submitted at any time.
III. Electronic Access
In order to receive ``Guidance for Industry, Supplements to
Approved Applications for Class III Medical Devices: 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 (380) 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 including text, graphics, and
files that may be downloaded to a personal computer with access to the
Web. Updated on a regular basis, the CDRH home page includes ``Guidance
for Industry, Supplements to Approved Applications for Class III
Medical Devices: Use of Published Literature, Use 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. This guidance is also available from CBER on
the World Wide Web at http://www.fda.gov/cber/guidelines.htm.
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 CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general
information, or arrow down for specific topics.
IV. Comments
Interested persons may, at any time, submit to the contact person
(address above) written comments regarding this final guidance. Such
comments will be considered when determining whether to amend the
current 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. The guidance document may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 18, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-13720 Filed 5-20-98; 8:45 am]
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