[Federal Register Volume 69, Number 141 (Friday, July 23, 2004)]
[Notices]
[Pages 44040-44041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16825]


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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; Final 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 revised final guidance entitled ``A Pilot Program to 
Evaluate a Proposed Globally Harmonized Alternative for Premarket 
Procedures; Guidance for Industry and FDA Staff.'' This revised 
guidance extends by 1 year a voluntary pilot premarket review program 
that may reduce the burden on manufacturers who face conflicting 
premarket submission format and content requirements in different 
countries. The pilot program is intended to evaluate the utility of an 
alternative submission procedure as described in the document entitled 
``Summary Technical Documentation for Demonstrating Conformity to the 
Essential Principles of Safety and Performance of Medical Devices'' 
(draft STED document). The draft STED document was developed by Study 
Group 1 (SG1) of the Global Harmonization Task Force (GHTF) and issued 
as a working draft in December 2000. 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. Each of these member countries will participate in 
the pilot program and will provide specific directions for implementing 
the program within their respective jurisdictions.

DATES: Submit written comments at any time. The pilot program is 
extended until June 25, 2005.

ADDRESSES: Submit written requests for single copies 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 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 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/opacom/backgrounder/voice.html. Comments are to 
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: Harry R. Sauberman, Center for Devices 
and Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-4879, e-mail: 
[email protected]; or Eric J. Rechen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186, e-mail: 
[email protected].

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 premarket review program and 
solicited 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 SG1 of the 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 this revised guidance, 
FDA is extending the pilot program for 1 more year. Other than updated 
contact information, there are no other changes to the guidance 
document. FDA received no comments on the guidance document. The 
revised guidance is a level 2 guidance under FDA's good guidance 
practices (GGPs) regulation (21 CFR 10.115). As such, FDA made the 
guidance available on its Web site on July 6, 2004.
    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

[[Page 44041]]

the following items: (1) Encourage convergence in regulatory practices 
with respect to ensuring the safety, effectiveness, performance, and 
quality of medical devices; (2) promote technological innovation; and 
(3) facilitate international trade. The GHTF's Web site can be accessed 
at http://www.ghtf.org. It provides further information concerning the 
organization's structure, goals, and procedures.
    The pilot premarket review program (STED pilot program), as 
implemented in the United States by FDA, will rely on the FDA final 
guidance that is the subject of this notice, and four related documents 
that are appended to the guidance. These documents are: (1) A letter to 
the global medical device industry announcing the pilot program 
(Appendix 1); (2) the draft STED document created by SG1 of GHTF 
(Appendix 2); (3) the GHTF SG1 final document entitled ``Essential 
Principles of Safety and Performance of Medical Devices,'' known as 
``Essential Principles'' (Appendix 3); and (4) the document entitled 
``The Least Burdensome Provisions of the FDA Modernization Act of 1997: 
Concept and Principles; Final Guidance for FDA and Industry,'' issued 
in October 2002 (Appendix 4).
    The FDA guidance document is intended to assist the medical device 
industry in making submissions to FDA that use the draft STED document 
format and are consistent with U.S. requirements. The announcement 
letter provides useful background and summary information regarding the 
proposed pilot premarket review program. The draft STED document 
describes a proposed internationally harmonized format and content for 
premarket submissions, e.g., PMA applications and 510(k) submissions in 
the United States, based on conformity to the Essential Principles. The 
Essential Principles are general and specific safety and performance 
recommendations for medical devices. They were developed by GHTF and 
are listed in the third document appended to the guidance. A discussion 
of the least burdensome provisions is provided in the fourth document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation 
(21 CFR 10.115). The guidance represents the agency's current thinking 
on a way to apply 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

    You may obtain a copy of ``A Pilot Program to Evaluate a Proposed 
Globally Harmonized Alternative for Premarket Procedures; Guidance for 
Industry and FDA Staff,'' via fax machine by calling 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.
    You may also obtain a copy of the guidance through 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. The CDRH home page is updated 
on a regular basis and includes: Civil money penalty guidance 
documents, device safety alerts, Federal Register reprints, information 
on premarket submissions (including lists of approved applications and 
manufacturers' addresses), assistance for small manufacturers, 
information on video conferencing, electronic submissions, mammography 
devices, and other device-related information. The CDRH home page may 
be accessed at http://www.fda.gov/cdrh.

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 paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: July 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-16825 Filed 7-22-04; 8:45 am]
BILLING CODE 4160-01-S