USA – FDA issues final guidance on inspections of medical device establishments

The US Food and Drug Administration (FDA) today published finalized guidance on inspections of medical device establishments. The final guidance follows a 28 March 2019 draft guidance, satisfying a requirement of the FDA Reauthorization Act of 2017 (FDARA).

The FDARA provision directs FDA to issue guidance specifying how it will implement uniform processes and standards that apply to inspection of both foreign and domestic establishments, other than for-cause inspections. (RELATED: FDA Drafts Guidance on Inspections of Medical Device Establishments, Regulatory Focus 28 March 2019)
 
Under FDARA, pre-announcement of inspections of device establishments should occur within a “reasonable time.” The guidance clarifies that domestic inspections will be pre-announced no less than 5 calendar days ahead of the inspection, while foreign inspection pre-announcements will generally occur more than 5 calendar days in advance of the inspection. Notifications for both foreign and domestic inspections, says the guidance, “should include information about the type and nature of the inspection, such as whether the inspection is scheduled as surveillance or pre-approval.”…