CDRH OTC Review Practice, BPAC, 051103
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CDRH Review Practice for Over-the-Counter
in Vitro Diagnostic Tests
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Center for Devices and Radiological
Health (CDRH)
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Office of in Vitro Diagnostic Device
Evaluation and Safety
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Arleen Pinkos
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Scientific Reviewer
I’ll be presenting a brief overview of CDRH review practices for OTC IVDs.
As a frame of reference……these products are…..
