[Federal Register Volume 65, Number 154 (Wednesday, August 9, 2000)]
[Notices]
[Pages 48719-48720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20088]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1274]


Guidance for Industry and for FDA Reviewers: Guidance on Section 
216 of the Food and Drug Administration Modernization Act of 1997; 
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 and for 
FDA Reviewers: Guidance on Section 216 of the Food and Drug 
Administration Modernization Act of 1997.'' This document provides 
guidance for industry on FDA's interpretation of the FDA Modernization 
Act of 1997 (FDAMA). The document describes how the Center for Devices 
and Radiological Health (CDRH) will apply the new provision and 
explains why FDA, through CDRH, has adopted this approach.

DATES: Submit written comments by November 7, 2000.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the guidance document entitled ``Guidance for Industry and for FDA 
Reviewers: Guidance on Section 216 of the Food and Drug Administration 
Modernization Act of 1997'' 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 concerning this guidance to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, by November 7, 2000. Submit written comments to 
the contact person listed below after November 7, 2000. Comments should 
be identified with the docket number found in brackets in the heading 
of this document. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Robert R. Gatling, Jr., Center for 
Devices and Radiological Health (HFZ-401), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 216 of FDAMA amended section 520(h)(4) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(h)(4)). Under the new 
provision, FDA can use certain information, contained in approved 
premarket approval applications (PMA's), 6 years after the application 
has been approved to:
    1. Approve another PMA;
    2. Determine whether a Product Development Protocol (PDP) has been 
completed;
    3. Establish a performance standard or a special control; or
    4. Classify or reclassify another device.
    Information available for the agency to use would include clinical 
and nonclinical tests or studies in the application that were used to 
demonstrate safety and effectiveness. However, it would exclude trade 
secret information such as manufacturing methods or device composition.
    This provision replaced the previous section 520(h)(4) of the act, 
which was added by the Safe Medical Devices Act of 1990 (SMDA) and 
established the

[[Page 48720]]

four-of-a-kind rule for use of data in PMA's. Under the four-of-a-kind 
rule, the agency could use data contained in any filed PMA 1 year after 
FDA had approved the fourth device of a kind. The four-of-a-kind 
provision also contained detailed rules for its application to data in 
applications approved before the SMDA's effective date. The SMDA 
provision replaced section 520(h)(3) of the act, which was enacted with 
the Medical Device Amendments of 1976 (MDA). Under the MDA, the agency 
could not use data in one PMA to establish the safety or effectiveness 
of any device other than the one for which the data was submitted.
    FDA is issuing this guidance in response to conflicting 
interpretations of section 216 of FDAMA advanced by regulated industry. 
FDA has concluded that it will apply section 216 to free data only in 
PMA's approved after November 28, 1990, the date of enactment of the 
SMDA. The agency does not intend to use data in PMA's approved before 
that date other than data that would be available to FDA without the 
authority granted by section 216 of FDAMA, such as published studies. 
The guidance also sets forth procedures for identifying and using data 
available under section 216 of FDAMA.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
section 216 of FDAMA. 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 being issued as a Level 1 guidance 
consistent with GGP's. This guidance document is effective immediately 
because it interprets a new statutory requirement that has been in 
effect since February 19, 1998.

III. Electronic Access

    In order to receive ``Guidance for Industry and for FDA Reviewers: 
Guidance on Section 216 of the Food and Drug Administration 
Modernization Act of 1997,'' via your fax machine, call the CDRH Facts-
On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone 
telephone. Press 1 to enter the system and enter the document number 
(1135) followed by the pound sign (#). Follow the remaining voice 
prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information, including text, graphics, and files that may be 
downloaded to a personal computer with access to the Internet. Updated 
on a regular basis, the CDRH home page includes, ``Guidance for 
Industry and for FDA Reviewers: Guidance on Section 216 of the Food and 
Drug Administration Modernization Act of 1997,'' 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.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this immediately-in-effect 
guidance by November 7, 2000. Submit to the contact person (address 
above) written comments regarding this guidance after November 7, 2000. 
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 and received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: July 27, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-20088 Filed 8-8-00; 8:45 am]
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