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Medical Devices / Inspections and Audits

MedTech Asks for Clarification on Inspection Guidance

July 12, 2019
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MedTech is asking the FDA to shed more light on its draft guidance on device establishment inspection processes and standards.

The group asked the agency to clarify that the devicemaker inspection requirements — such as providing advance notice of inspections and giving an expected timeframe — “will apply to the inspection of any device or device component of a combination product, regardless of the FDA Center that has jurisdiction over the device.”

The agency’s guidance explains the agency’s standards for inspections of medical device facilities both at home and abroad and clarifies the methods of communication the FDA uses during the inspection process.

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