FDA Issues Updated Processes for Device Inspections

April 1, 2019

The FDA issued new guidance updating its protocols for timeframes and communications during inspections of medical device manufacturing plants.

The guidance explains that the agency considers its “reasonable estimated timeframes of inspections” to be between three to six business days, depending on the type of surveillance inspection and coverage needed for a pre-approval inspection.

The agency also said that its investigators should make every effort to discuss their observations with facility management to “minimize errors and misunderstandings.” The discussions can be recorded by either the agency or the firm with prior agreement.

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