Out At Home: FDA’s Vocal Support of Home Testing but Reluctance to Clear Novel OTC Home Tests
FDA Law
JUNE 22, 2023
As a result, novel IVD manufacturers are more likely to start with clearance of a prescription test intended for use in clinical settings with the thought that one day in the future, after several years of clinical experience demonstrating safe use, they may return to FDA to seek clearance of an OTC version.
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