[Federal Register Volume 64, Number 22 (Wednesday, February 3, 1999)]
[Notices]
[Pages 5300-5301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2508]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-1232]


Points To Consider Guidance Document on Assayed and Unassayed 
Quality Control Material; 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availability of the draft guidance entitled ``Points To Consider 
Guidance Document on Assayed and Unassayed Quality Control Material.'' 
This draft guidance is neither final nor is it in effect at this time. 
This draft guidance is intended to provide assistance to manufacturers 
of in vitro diagnostic quality control materials. It complements the 
existing guidance on labeling of these devices entitled `` Points to 
Consider for Review of Calibration and Quality Control Labeling for In 
Vitro Diagnostic Device.''

DATES: Written comments concerning this draft guidance must be received 
by May 4, 1999.

ADDRESSES: Written comments concerning this draft guidance must be 
submitted to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit written requests for single copies on a 3.5'' diskette of the 
draft guidance

[[Page 5301]]

document entitled ``Points To Consider Guidance Document on Assayed and 
Unassayed Quality Control Material'' 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. Comments 
should be identified with the docket number found in brackets in the 
heading of this document. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Joseph L. Hackett, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3084.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance, entitled ``Points to Consider Guidance 
Document on Assayed and Unassayed Quality Control Materials,'' 
complements the existing guidance document published in February 1996, 
entitled ``Points to Consider for Review of Calibration and Quality 
Control Labeling for In Vitro Devices.'' FDA believes information in 
this draft guidance concerning unassayed quality control materials may 
be useful to manufacturers making these products, even though such 
materials are currently exempt from premarket review. For assayed 
quality control materials, the intent is for this draft guidance 
document to eventually be cited as the basis for abbreviated 510(k)'s 
for processing of assayed controls.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on assayed and unassayed quality control materials. 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 Good Guidance Practices (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 draft guidance document is issued as a Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    In order to receive ``Points To Consider Guidance Document on 
Assayed and Unassayed Quality Control Material'' 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 (2231) 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 may 
also do so using the World Wide Web (WWW). CDRH maintains an entry on 
the WWW for easy access to information including text, graphics, and 
files that may be downloaded to a personal computer with access to the 
Web. Updated on a regular basis, the CDRH home page includes ``Points 
to Consider for Guidance Document on Assayed and Unassayed Quality 
Control Material,'' 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''.

IV. Comments

    Interested persons may, on or before May 4, 1999, submit to Docket 
Management Branch (address above) written comments regarding this draft 
guidance. 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 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: January 19, 1999.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 99-2508 Filed 2-2-99; 8:45 am]
BILLING CODE 4160-01-F