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U.S. Department of Health and Human Services

For Industry

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What medical devices does CBER regulate?

CBER regulates all tests (referred to as in vitro diagnostics) used for blood donor screening. This includes but is not limited to tests such as HIV, HTLV 1/2, and hepatitis B and C viruses. CBER also regulates medical devices used for blood collection and processing, as well as cellular therapies regulated by CBER. FDA’s Center for Devices and Radiological Health (CDRH) regulates all other in vitro diagnostic tests for HBV, HCV, etc., with the important exception of HIV diagnostic tests. CBER regulates all HIV test kits marketed in the US. A listing of devices regulated by CBER may be found on the web.

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