[Federal Register: July 25, 2001 (Volume 66, Number 143)]
[Notices]
[Page 38714-38716]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy01-116]
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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Harmonized Alternative for Premarket Procedures; Draft Guidance for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availability of the draft guidance entitled ``A Pilot Program to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 This draft guidance is intended to assist the medical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diskette of the draft guidance document entitled ``A Pilot Program to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 Submit written or electronic comments concerning this draft
guidance to the Dockets Management Branch (HFA-305), Food and Drug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.
[[Page 38716]]
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