Thursday, January 19, 2006

FDA to change herpes test classification

Following up on last week's post on this subject, I have tracked down the specific proposal at the FDA regarding changes to the guidelines for herpes tests.

The specific rule change is published in the January 9 issue of the Federal Register, pp. 1399-1403. The rule change places some herpes tests under less restrictive requirements with some special controls. The Federal Register notice outlines the history of the issue and provides reasons for the change. Comments are due by April 10. (See the notice for the specifics of where to comment--and remember that your comments will be available to the public, including any personal information that you submit.)

A draft of the guidance document for the special controls which will accompany reclassification are published in the same issue of the Federal Register and also on the FDA's web page: "Draft Guidance for Industry and FDA Staff--Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays" (also available in PDF). This document is also open for public comment.

3 comments:

STDromancedotcom said...

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STDromancedotcom said...

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