CDRH is the Center within the FDA responsible for protecting the public health by providing reasonable assurance of the safety and effectiveness of medical devices and by eliminating unnecessary human exposure to radiation emitted by electronic products. The Office of In Vitro Diagnostic Devices (OIVD) is the office within CDRH that reviews most in vitro diagnostic products.
Center for Devices and Radiological Health
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Glossary Terms
In Vitro Diagnostic
(IVD)