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Reclassification of Hepatitis A Virus Serological Assays and Availability of Class II Special Controls Guidance for Hepatitis A Virus Serological Assays

FDA is issuing a final rule to reclassify hepatitis A virus (HAV) serological assays from class III (premarket approval) into class II (special controls). FDA is taking this action after reviewing a reclassification petition submitted by Beckman Coulter, Inc.

FDA is also making available a guidance entitled, ‘‘Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays’’ that will serve as the class II special control for these devices.

HAV serological assays are in vitro diagnostic devices used to test for specific antibodies to support the clinical laboratory diagnosis of HAV.

This rule is effective March 13, 2006.

For more information on these updates, please refer to the following links:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06-1206.pdf and
http://www.fda.gov/OHRMS/DOCKETS/98fr/06-1207.pdf

If you have any comments regarding this update, please email: info@mdiconsultants.com

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