FDA to Develop Accreditation System for Evaluating Medical Devices

With a new set of Medical Device User Fee Amendments (MDUFA IV) making their way through Congress, the Food and Drug Administration (FDA) is getting a jump-start on a plan to recognize accredited testing laboratories. Under this scheme, the agency would use standardized test reports from these laboratories during premarket reviews as evidence of conformity by manufacturers.

The agency is asking for feedback on its proposal, which it outlined in a Federal Register notice published May

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