[Federal Register Volume 66, Number 150 (Friday, August 3, 2001)]
[Notices]
[Pages 40708-40709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19462]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0262]


Draft ``Guidance for FDA Reviewers: Premarket Notification 
Submissions for Automated Testing Instruments Used in Blood 
Establishments;'' 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 draft document entitled ``Guidance for FDA Reviewers: 
Premarket Notification Submissions for Automated Testing Instruments 
Used in Blood Establishments'' dated August 2001. The draft guidance 
document provides an overview of the type of information FDA reviewers 
should expect to be included in premarket notifications submitted to 
the Center for Biologics Evaluation and Research (CBER) for such 
devices and the approach FDA reviewers should take in reviewing 
premarket submissions for automated instruments used for testing in 
blood establishments. This document, when finalized, is intended for 
use by establishments that manufacture blood and blood components 
(e.g., in testing for blood borne pathogens, blood grouping/typing, 
pre-transfusion compatibility, etc.).

DATES: Submit written comments on the draft guidance to ensure their 
adequate consideration in preparation of the final document by November 
1, 2001. General comments on agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448. Send one self-addressed adhesive label to assist the 
office in processing your requests. The document may also be obtained 
by mail by calling the CBER Voice Information System at 1-800-835-4709 
or 301-827-1800, or by fax by calling the FAX Information System at 1-
888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael Anderson, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for FDA Reviewers: Premarket Notification Submissions for 
Automated Testing Instruments Used in Blood Establishments'' dated 
August 2001. The purpose of a premarket notification (510(k)) 
submission is to demonstrate that the medical device to be marketed is 
substantially equivalent to a device that is already legally marketed. 
The draft guidance presents an overview of the type of information FDA 
reviewers should expect to be included in premarket notifications 
submitted to CBER for automated testing instruments used for testing in 
blood establishments, and clarifies the approach FDA reviewers should 
take in reviewing these types of premarket submissions. These automated 
testing instruments are routinely used for detection of blood borne 
pathogens, blood grouping/typing, and in pre-transfusion compatibility 
testing.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115; 65 FR 56468, September 
19, 2000). This draft guidance document represents the agency's current 
thinking on the review of premarket notification submissions for 
automated instruments used for testing in blood establishments. It does 
not create or confer any rights for or on

[[Page 40709]]

any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirement of the applicable statutes and regulations.

II. Comments

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit to the Dockets Management Branch (address 
above) written comments regarding this draft guidance document. Submit 
written comments to ensure adequate consideration in preparation of the 
final document by November 1, 2001. Two copies of any comments are to 
be submitted, except individuals may submit one copy. Comments should 
be identified with the docket number found in the brackets in the 
heading of this document. A copy of the document and received comments 
are available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: June 29, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-19462 Filed 8-2-01; 8:45 am]
BILLING CODE 4160-01-S