You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document contact Alexandra Wong at 301-796-6210 or by email at


U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Office of In Vitro Diagnostic Device Evaluation and Safety

Division of Microbiology Devices


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  7. 21 CFR Parts 800 to 1299. Revised as of April 1, 2009.