The Food and Drug Administration (FDA) issued guidance on inspections of medical device establishments. The finalized document follows draft guidance issued on March 28, 2019, filling a requirement of the FDA Reauthorization Act of 2017 (FDARA).

The guidance specifies how the Agency will implement uniform processes and standards that are related to inspections of foreign and domestic device establishments. It also describes standardized methods of communication during the inspection process and identifies practices for investigators and device establishments to enable the continuity of inspections of such establishments.

Pre-announcement Notice and Communication

FDARA indicates a ‘reasonable time’ within which the pre-announcement of inspections of device establishment should take place. National inspections will be pre-announced no less than 5 calendar days in advance of the inspection, while pre-announcement of foreign inspection will generally take place more than 5 calendar days before the inspection.

Standard Inspection Timeframe

FDA standards for reasonably estimated timeframes of inspections generally range from 3 to 6 continuous business days and are based on the type of surveillance inspection and the extent of covered required for a pre-approval review. Additionally, it may be necessary to extend the duration of an inspection for a “number of reasons”.

Communication During Inspections

FDA states in its guidance that regular verbal communications during the inspection about its status between the investigator and the owner, operator, or agent in charge of the device establishment should be maintained.

For more details, please see the FDA guidance.

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:

Contact Meditrial for immediate assistance in Europe or the US.