Draft Guidance for Industry and FDA - Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens.’’ This draft guidance provides guidance on the types of information and data to consider when preparing or reviewing premarket submissions for nucleic acid based in vitro diagnostic devices for the detection of microbial pathogens. This draft guidance replaces ‘‘Review Criteria for Nucleic Acid Amplification based in vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms’’ that was issued in June 1993. The current document reflects changes in the technologies available for nucleic acid detection, and expanded use in clinical laboratories.

The FDA is accepting written or electronic comments on this draft guidance till March 8, 2006.

For more information pertaining to this update, refer to: http://www.fda.gov/OHRMS/DOCKETS/98fr/05-23746.pdf

To view the Draft Guidance, refer to: http://www.fda.gov/cdrh/oivd/guidance/1560.pdf

If you have comments regarding this update, please email us at info@mdiconsultants.com.

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