Draft “Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments;” Withdrawal of Guidance
The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance that was issued on August 3, 2001.
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DATES: Back to Top
June 28, 2005.
FOR FURTHER INFORMATION CONTACT: Back to Top
Paul E. Levine, Jr., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION: Back to Top
In a notice published in the Federal Register of August 3, 2001 (66 FR 40708), FDA announced the availability of a draft document entitled “Guidance for FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments.” This draft guidance is being withdrawn because it no longer reflects the following: (1) All of the information FDA reviewers should expect to be included in a premarket notification submitted to the Center for Biologics Evaluation and Research for such devices and (2) the recommended approach FDA reviewers should take in reviewing premarket submissions for automated instruments testing used in blood establishments. In the future, FDA may issue for public comment draft special control guidances on instrumentation for blood borne pathogen donor screening and immunohematology testing.
Dated: June 20, 2005.
Assistant Commissioner for Policy.
[FR Doc. 05-12763 Filed 6-27-05; 8:45 am]
BILLING CODE 4160-01-S