[Federal Register Volume 63, Number 98 (Thursday, May 21, 1998)]
[Notices]
[Pages 27988-27989]
From the Federal Register Online via the Government Publishing 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]
BILLING CODE 4160-01-F