[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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availability of the draft guidance document entitled ``Draft Global 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The draft guidance document has been created by members of the 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agency is requesting public comment regarding the draft guidance 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DATES:  Written comments concerning this draft guidance document must 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ADDRESSES: Submit written comments concerning the draft guidance 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written requests for single copies on a 3.5'' diskette of the draft 
guidance document to the Division of Small Manufacturers Assistance 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Information section for information on electronic access to the draft 
guidance document.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 ``<a href="http://
www.fda.gov/cdrh/comp/ghtfproc.pdf">http://
www.fda.gov/cdrh/comp/ghtfproc.pdf</a>''.
    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