[Federal Register Volume 70, Number 217 (Thursday, November 10, 2005)]
[Notices]
[Pages 68465-68466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22387]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D-0281]


Medical Devices: A Pilot Program to Evaluate a Proposed Globally 
Harmonized Alternative for Premarket Procedures; 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 a guidance entitled ``A Pilot Program to Evaluate a 
Proposed Globally Harmonized Alternative for Premarket Procedures; 
Guidance for Industry and FDA Staff.'' The revised guidance extends the 
voluntary pilot premarket review program Summary Technical 
Documentation (STED pilot) until we have received an adequate number of 
submissions to evaluate the STED pilot. The pilot program is intended 
for evaluating the utility of an alternative submission procedure.

DATES: Submit written or electronic comments on the guidance at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``A Pilot Program to 
Evaluate a Proposed Globally Harmonized Alternative for Premarket 
Procedures; Guidance for Industry and FDA Staff'' to the Division of 
Small Manufacturers, International, and Consumer Assistance (HFZ-220), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818. See SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Harry R. Sauberman, Center for Devices 
and Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-4879, or Kenneth J. 
Cavanaugh Jr., Center for Devices and Radiological Health (HFZ-450), 
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850, 301-443-8517.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 26, 2003 (68 FR 38068), FDA 
announced the availability of a guidance document entitled ``A Pilot 
Program to Evaluate a Proposed Globally Harmonized Alternative for 
Premarket Procedures; Guidance for Industry and FDA Staff.'' The 
guidance document announced a pilot program for a premarket review 
program and encouraged participation from the medical device industry. 
The pilot program is intended to evaluate the utility of an alternative 
submission procedure as described in the draft STED document prepared 
by Study Group 1 of the Global Harmonization Task Force (GHTF). The 
document seeks to harmonize the different requirements for premarket 
submissions in various countries.
    The June 26, 2003, guidance and notice of availability announced 
that the pilot program would be in effect for 1 year from the date of 
publication of the notice of availability. In the Federal Register of 
July 23, 2004 (69 FR 44040), the pilot program was subsequently 
extended until June 25, 2005. FDA has received no comments on the 
guidance issued on June 26, 2003, or the updated version published on 
July 23, 2004. In this revised guidance, FDA is extending the pilot 
program until we have received a sufficient number of submissions to 
evaluate the pilot program. In addition, FDA is updating the contact 
information and the references to the GHTF documents, along with other 
minor editorial changes. The FDA guidance document is intended to 
assist the medical device industry in making submissions to FDA that 
use a proposed internationally harmonized format and content for 
premarket submissions, e.g., premarket approval applications and 510(k) 
submissions in the United States. The revised guidance is a level 2 
guidance under FDA's good guidance practices (GGPs) regulation (21 CFR 
10.115). FDA made the guidance available on its Web site at http://www.fda.gov/cdrh/ode/guidance/1347.html.
    The GHTF is a voluntary group comprised of medical device 
regulatory officials and industry representatives from the United 
States, Canada, Australia, the European Union, and Japan. The goals of 
the GHTF include the following items: (1) Encourage convergence in 
regulatory practices with respect to ensuring the safety, 
effectiveness, performance, and quality

[[Page 68466]]

of medical devices; (2) promote technological innovation; and (3) 
facilitate international trade. GHTF provides further information 
concerning the structure, goals, and procedures at the GHTF Web site 
and can be accessed at http://ghtf.org.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's Good Guidance 
Practice (GGP) regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on the GHTF recommendations as related to 
premarket submission 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 
requirements of the applicable statute and regulations.

III. Electronic Access

    To receive a copy of ``A Pilot Program to Evaluate a Proposed 
Globally Harmonized Alternative for Premarket Procedures; Guidance for 
Industry and FDA Staff,'' by fax call 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 
<greek-i>. Follow the remaining voice prompts to complete your request.
    To receive ``A Pilot Program to Evaluate a Proposed Globally 
Harmonised Alternative for Premarket Procedures; Guidance for Industry 
and FDA Staff,'' you may either send a fax request to 301-443-8818 to 
receive a hard copy of the document, or send an e-mail request to 
<a href="/cdn-cgi/l/email-protection#84e3f3e5c4e7e0f6ecaae2e0e5aae3ebf2"><span class="__cf_email__" data-cfemail="3057475170535442581e5654511e575f46">[email protected]</span></a> to receive a hard copy or an electronic copy. Please 
use the document number 1347 to identify the guidance you are 
requesting.
    Persons interested in obtaining a copy of the guidance may also do 
so by 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: Device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's, information on video conferencing, 
and electronic submissions, Mammography Matters, and other device-
related information. The CDRH web site home page may be accessed at 
http://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed 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. Comments received may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 2, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22387 Filed 11-9-05; 8:45 am]
BILLING CODE 4160-01-S


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