[Federal Register Volume 66, Number 143 (Wednesday, July 25, 2001)]
[Notices]
[Pages 38714-38716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18480]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0281]


Medical Devices; A Pilot Program to Evaluate a Proposed Globally 
Harmonized Alternative for Premarket Procedures; Draft Guidance for 
Industry and FDA Staff; 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availability of the draft guidance entitled ``A Pilot Program to 
Evaluate a Proposed Globally Harmonized Alternative for Premarket 
Procedures.'' This draft guidance is intended to assist the medical 
device industry and FDA staff in implementing a pilot premarket review 
program that may reduce some of the burden on manufacturers associated 
with current conflicting format and content requirements in different 
countries. The proposed pilot program will evaluate the utility of two 
documents created by the Global Harmonization Task Force (GHTF), Study 
Group 1 (SG1), entitled ``Summary Technical Documentation for 
Demonstrating Conformity to the Essential Principles of Safety and 
Performance of Medical Devices (STED)'' and ``Essential Principles of 
Safety and Performance of Medical Devices'' (Essential Principles). The 
GHTF is a voluntary group of representatives from national medical 
device regulatory authorities and the regulated industry. This guidance 
is neither final nor is it in effect at this time.

DATES: Submit written or electronic comments concerning this draft

[[Page 38715]]

guidance and the related GHTF documents by September 24, 2001.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``A Pilot Program to 
Evaluate a Proposed Globally Harmonized Alternative for Premarket 
Procedures'' and related GHTF documents to the Division of Small 
Manufacturers Assistance (HFZ-220), Center for Devices and Radiological 
Health (CDRH), 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 Submit written or electronic comments concerning this draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Timothy A. Ulatowski, Center for 
Devices and Radiological Health (HFZ-480), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8879.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is conducting a pilot premarket review program and is 
soliciting participation from the medical device industry. The pilot 
program is intended to evaluate the utility of a draft document that 
was prepared by the GHTF, SG1, to help harmonize the different 
requirements for premarket submissions in various countries. The GHTF 
is a voluntary group of representatives from national medical device 
regulatory authorities and the regulated industry. The purpose of the 
GHTF is to: (1) Encourage convergence in regulatory practices relating 
to ensuring the safety, effectiveness/performance, and quality of 
medical devices; (2) promote technological innovation; and (3) 
facilitate international trade. The GHTF Web site at: http://www.ghtf.org describes its organization, goals, and procedures. The 
GHTF draft document describes an internationally harmonized format and 
content for premarket submissions, e.g., premarket approval 
applications (PMAs) and 510(k) submissions, based on conformity to the 
Essential Principles document. The Essential Principles are a GHTF-
derived list of both general and specific safety and performance 
recommendations for medical devices.
    The announcement of the pilot premarket review program consists of 
the FDA draft guidance, which is the subject of this notice, and three 
related documents for comment appended to the FDA draft guidance: (1) A 
draft letter to the global medical device industry announcing the pilot 
program; (2) the draft STED document created by GHTF, SG1; and (3) the 
GHTF final document entitled ``Essential Principles of Safety and 
Performance of Medical Devices.''
    The draft guidance document is intended to assist the medical 
device industry in completing a submission to FDA that uses the draft 
STED format and is also in accordance with U. S. requirements. The 
announcement letter describes specifics regarding the proposed pilot 
premarket program. The Essential Principles document is referenced in 
the draft STED document.
    Four of the founding members of the GHTF are participating in the 
pilot program. They include the United States, Canada, Australia, and 
the European Union. Each of the participants will provide specific 
directions for implementing the pilot program within its jurisdiction.
    The GHTF wants to assess the international utility of the draft 
STED document. Therefore, SG1 of the GHTF encourages manufacturers to 
prepare and submit, if submission is required, STEDs for the same 
device to as many of the four participating GHTF member countries as 
possible. SG1 also encourages manufacturers to try the draft STED 
format for different classes of devices that are candidates for the 
pilot program.
    FDA intends to process premarket submissions in the draft GHTF 
harmonized format within statutory time limits and with review times 
comparable to other submissions for similar products. There will be no 
expedited review of submissions, unless the device merits such a 
process under current policies.
    FDA plans to conduct the pilot program for 1 year. The pilot 
program will begin on the date of publication of the final FDA guidance 
document. FDA will assess how the pilot is proceeding during its course 
and may choose to decline receipt of additional submissions using the 
draft STED format in order to assess the initial experiences. At the 
end of the pilot, FDA and other GHTF participants will analyze the 
outcome to determine whether the draft STED document is a viable 
alternative to current premarket submission procedures, and if the 
program should be continued or expanded. FDA will post on its Web site 
a report of the outcome of the pilot program.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on one possible way to evaluate and apply GHTF recommendations 
related to premaket submissions to FDA. 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 statutes and regulations.
    The agency has adopted good guidance practices (GGPs), and 
published the final rule, which set forth the agency's regulations for 
the development, issuance, and use of guidance documents ( 21 CFR 
10.115; 65 FR 56468, September 19, 2000). This draft guidance document 
announcing the pilot is issued as a level 1 guidance in accordance with 
the GGP regulations.

III. Electronic Access

    In order to receive a copy of the draft guidance entitled ``A Pilot 
Program to Evaluate a Proposed Globally Harmonized Alternative for 
Premarket Procedures'' 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. At the second voice prompt 
press 1 to order a document. Enter the document number (1347) followed 
by the pound sign (#). Follow the remaining voice prompts to complete 
your request.
    Persons interested in obtaining a copy of the draft 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 Internet access. Updated 
on a regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, 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. Guidance documents are also available on the Dockets Management 
Branch Web site at http://www.fda.gov/ohrms/dockets/default.htm.

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IV. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written or electronic comments regarding this draft guidance by 
September 24, 2001. Submit two copies of any comments, 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 
draft 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 13, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-18480 Filed 7-24-01; 8:45 am]
BILLING CODE 4160-01-S