[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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