[Federal Register Volume 59, Number 6 (Monday, January 10, 1994)]
[Notices]
[Pages 1402-1403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-466]
[[Page Unknown]]
[Federal Register: January 10, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 88D-0087]
Manufacture of in Vitro Diagnostic Products; Current Good
Manufacturing Practice Final Guideline; 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 final guideline entitled ``Guideline for the
Manufacture of In Vitro Diagnostic Products'' that contains production
practices which are acceptable to FDA for assuring the safety and
effectiveness of in vitro diagnostic products. Manufacturers of in
vitro diagnostic products may find the information in the guideline
useful in developing procedures that comply with the current good
manufacturing practice (CGMP) regulations for these products. A draft
document was previously made available for public comment.
DATES: Comments by March 11, 1994.
ADDRESSES: Submit written requests for single copies of the final
guideline to the Division of Small Manufacturers Assistance (HFZ-220),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-443-6597 (toll free outside MD 800-638-2041). Send two self-
addressed adhesive labels to assist that office in processing your
requests. Submit written comments on the final guideline to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857. Requests and comments should
be identified with the docket number found in brackets in the heading
of this document. The final guideline and received comments are
available for public examination in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Z. Frank Twardochleb, Center for
Devices and Radiological Health (HFZ-300), Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1128.
SUPPLEMENTARY INFORMATION: FDA first announced the availability for
public comment of the draft guideline in the Federal Register of April
7, 1988 (53 FR 11561). In that same issue of the Federal Register (53
FR 11561), FDA announced the forthcoming meeting of the agency's Device
Good Manufacturing Practice Advisory Committee (the committee). As a
result of the notice and the open public meeting, FDA received 17
letters providing comments--14 from manufacturers, 2 from trade
associations, and 1 from an attorney representing a manufacturer.
Presentations before the committee by industry and FDA resulted in
committee recommendations that the agency: (1) Continue to handle the
document as a guideline; (2) change the title and/or scope of the
document to clarify which products are subject to the guideline; and
(3) extend the comment period from June 6, 1988 to July 15, 1988.
FDA extended the comment period as recommended by the committee and
revised the guideline based on the comments received. A notice of
availability of the second draft was published in the Federal Register
of April 19, 1990 (55 FR 14863).
Since release of the second draft, four letters of comment have
been received from two trade associations, one manufacturer, and one
user association. Meetings have also been held with the two trade
associations--the Association of Microbiological Diagnostic
Manufacturers and the Health Industry Manufacturers Association. A
total of 21 letters of comment were received in response to all
notices. These comments are on file with the Dockets Management Branch
under Docket No. 88D-0087.
The notice of availability of the draft guideline stated that it
would be issued under Sec. 10.90(b) (21 CFR 10.90(b)), which provides
for the use of guidelines to establish procedures or standards of
general applicability that are not legal requirements but that are
acceptable to the agency. The agency is now in the process of
considering whether to revise Sec. 10.90(b). Although that decision has
not been made, the agency has decided to publish this guideline.
However, this notice and the final guideline are not being issued under
the authority of Sec. 10.90(b), and the final guideline, although
called a guideline, does not operate to bind FDA or any other person in
any way. The agency advises that this final guideline represents its
current position on the requirements of the CGMP regulations for in
vitro diagnostic products. The guideline may be useful to manufacturers
of in vitro diagnostic products. A person may also choose to use
alternate procedures even though they are not provided for in the
guideline. If a person chooses to depart from the practices and
procedures set forth in the final guideline, that person may wish to
discuss the matter further with the agency to prevent an expenditure of
money and effort on activities that may later be determined to be
unacceptable by FDA. This guideline does not bind the agency, and it
does not create or confer any rights, privileges, or benefits for or on
any person.
On November 23, 1993 (58 FR 61952), FDA issued a notice of proposed
rulemaking to revise the medical device CGMP regulations. Any revisions
to the CGMP regulations may result in the need for changes to this
guideline. Therefore, on issuing a final rule to revise the CGMP
regulations, FDA will review the guideline and make any necessary
changes.
Copies of this final guideline, along with previous drafts and
submitted comments, are available for public examination in the Dockets
Management Branch (address above).
Interested persons may submit written comments on the final
guideline to the Dockets Management Branch. Additional comments will be
considered in determining the future need for amending the final
guideline. Two copies of comments should be submitted, except that
individuals may submit one copy. Comments should be identified with the
docket number found in brackets in the heading of this document.
Dated: January 4, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-466 Filed 1-7-94; 8:45 am]
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