[Federal Register Volume 63, Number 136 (Thursday, July 16, 1998)]
[Notices]
[Pages 38411-38412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0508]
Medical Devices: Draft Global Harmonization Task Force Study
Group 3 Process Validation Guidance; Draft; 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availability of the draft guidance document entitled ``Draft Global
Harmonization Task Force Study Group 3 Process Validation Guidance.''
The draft guidance document has been created by members of the
International Global Harmonization Task Force Study Group 3 (GHTF SG3)
to propose harmonized international process validation technical
requirements and guidance for the manufacture of medical devices. The
agency is requesting public comment regarding the draft guidance
document as proposed by the GHTF SG3. Because FDA intends to utilize
the GHTF document as guidance for the agency and industry, FDA is also
publishing this document for comment under its good guidance practices
(GGP's).
DATES: Written comments concerning this draft guidance document must
be received by August 14, 1998.
ADDRESSES: Submit written comments concerning the draft guidance
document entitled ``Draft Global Harmonization Task Force Study Group 3
Process Validation Guidance'' to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Comments should be identified with the docket
number found in brackets in the heading of this document. Submit
written requests for single copies on a 3.5'' diskette of the draft
guidance document to the Division of Small Manufacturers Assistance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. See the Supplementary
Information section for information on electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Collin L. Figueroa, Center for Devices
and Radiological Health (HFZ-341), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-4648.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
governmental regulatory authorities, industry associations, and
individual sponsors to promote the international harmonization of
regulatory requirements. FDA has participated in numerous efforts to
enhance this harmonization and has expressed its commitment to promote
the international harmonization of regulatory requirements. As part of
this effort, FDA has been actively involved in a Global Harmonization
Task Force (GHTF). The GHTF has subsequently formed four study groups,
each tasked with aspects designed to facilitate global harmonization.
Study Group 3 of the GHTF drafted the process validation guidance
to harmonize quality systems requirements
[[Page 38412]]
to ensure manufactured products meet their intended requirements. FDA
is committed to publicizing the work product of the GHTF study groups
and encourages dissemination of these harmonization documents. Because
FDA intends to utilize this GHTF document as guidance for the agency
and industry, FDA also is publishing this document for comment under
its GGP's. The information and guidance contained in the draft document
is intended to help manufacturers understand quality system
requirements that involve process validation and how process validation
relates to product design and corrective actions.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking on global harmonization and process validation. 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 statute, regulations, or both.
The agency has adopted GGP's, which set forth the agency's policies
and procedures for the development, issuance, and use of guidance
documents (62 FR 8961, February 27, 1997). This guidance document is
issued as a Level 1 guidance consistent with GGP's.
III. Electronic Access
In order to receive the ``Draft Global Harmonization Task Force
Study Group 3 Process Validation Guidance'' via your fax machine, call
the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-0111
from a touch-tone telephone. At the first voice prompt press 1 to
access DSMA Facts, at second voice prompt press 2, and then enter the
document number 2268 followed by the pound sign (#). Then follow the
remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance
document may also do so using the World Wide Web (WWW). The Center for
Devices and Radiological Health (CDRH) maintains an entry on the WWW
for easy access to information including text, graphics, and files that
may be downloaded to a PC with access to the Web. Updated on a regular
basis, the CDRH home page includes ``Draft Global Harmonization Task
Force Study Group 3 Process Validation Guidance,'' 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. The ``Draft Global Harmonization Task Force
Study Group 3 Process Validation Guidance'' will be available at
``http://www.fda.gov/cdrh/comp/ghtfproc.html'' and ``http://
www.fda.gov/cdrh/comp/ghtfproc.pdf''.
A text-only version of the CDRH Web site is also available from a
computer or VT-100 compatible terminal by dialing 800-222-0185
(terminal settings are 8/1/N). Once the modem answers, press Enter
several times and then select menu choice 1: FDA BULLETIN BOARD
SERVICE. From there follow instructions for logging in, and at the BBS
TOPICS PAGE, arrow down to the FDA home page (do not select the first
CDRH entry). Then select MEDICAL DEVICES AND RADIOLOGICAL HEATLH. From
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general
information, or arrow down for specific topics.
IV. Comments
Interested persons may, on or before August 14, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this draft guidance document. Two copies of any comments are to be
submitted, 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 9, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-19109 Filed 7-14-98; 12:30 pm]
BILLING CODE 4160-01-F
