[Federal Register: July 23, 2004 (Volume 69, Number 141)]
[Notices]
[Page 44040-44041]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy04-80]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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:
hrs@cdrh.fda.gov; 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:
ejr@cdrh.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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