FDA classify Medical Devices and how to report device problems: A Systematic Review – Pubrica
Introduction The FDA's Center for Devices and Radiological Health (CDRH) oversees device regulation. A device is defined as "an apparatus, instrument, contrivance, implement, machine, implant, or in vitro reagent" that meets three criteria: 1) it is recognised in the official National Formulary or the United States Pharmacopeia; 2) it is intended for use in the diagnosis of disease or other...
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