Device Makers To Get At Least Five Days Advance Notice For FDA Inspections: Guidance

A newly finalized FDA guidance on device firm inspection procedures recommends a five-day advance warning, three- to six-day inspections and lots of verbal communication throughout the process.

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The COVID-19 pandemic has hit a temporary pause button on routine inspections of device firms by the US Food and Drug Administration. But background work on inspections continues, and that includes a new final guidance document offering guidelines on how the agency will conduct device establishment inspections.

The document, which was published 25 June, finalizes a draft guidance issued in March 2019. The FDA Reauthorization Act (FDARA)...

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