01-19462. 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.

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 The draft guidance document provides an overview of the type of information FDA reviewers should expect to be included in premarket notifications submitted to the Center for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Submit written comments on the draft guidance to ensure their adequate consideration in preparation of the final document by November 1, 2001.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Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.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 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.