AAB Proficiency Testing

FDA's Draft Guidance for IVDMIAs

Draft Guidance for Industry, clinical Laboratories, and FDA Staff

Federal Register, July 26, 2007

The U.S. Food and Drug Administration (FDA) has issued an updated "Draft Guidance" regarding In Vitro Diagnostic Multivariate Index Assays (IVDMIAs).

Comments and suggestions regarding this draft document should be submitted on or before August 27, 2007.

Submit written comments to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852.

Submit electronic comments to http://www.fda.gov/dockets/ecomments.

All comments should be identified with the docket number 2006D-0347.

Also, please copy AAB on your comments by email: aab@aab.org, fax: 314-241-1449, or mail: AAB, 906 Olive Street, Suite 1200, St. Louis, MO 63101-1434.

 

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