FDA Issues Guidance on Procedures for Device Establishment Inspections

On June 29, 2020, the U.S. Food & Drug Administration (FDA) issued guidance on how it will implement certain inspection procedures with respect to device establishments—facilities where medical devices are manufactured. The FDA’s guidance contains recommendations about (1) preannouncement notice (and communications prior to an establishment inspection); (2) inspection durations and timeframes; and (3) communications between the establishment’s representative and FDA’s inspector(s) during the inspection process.

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