FDA issues final guidance on inspections of medical device establishments

Regulatory NewsRegulatory News | 26 June 2020 |  By 

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 The final guidance follows a 28 March 2019 draft guidance, satisfying a requirement of the FDA Reauthorization Act of 2017 (FDARA).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.”
A “reasonable estimated timeframe” for inspection will ordinarily range from 3 to 6 continuous business days, according to the guidance. The type of surveillance inspection and the extent of covered required for a pre-approval inspection will guide the inspection duration; other factors such as the complexity of operations, staff availability and the nature of any observed deficiencies will also affect inspection duration.
An inspection may be extended “for a number of reasons,” says the guidance. These may include the need to follow up on post-market safety information. However, “unless an investigator or the firm identifies a reason that additional time is needed and communicates this verbally to the other party, inspections of both domestic and foreign device establishments should take place within a standard timeframe and occur over consecutive business days,” according to the guidance. Inspectors should verbally communicate any exceptions to these time frames to establishment representatives during the inspection.
In general, inspectors should maintain regular verbal communication during the inspection with appropriate representatives of establishments undergoing inspection. “When time and circumstances permit, investigators should make every reasonable effort to discuss all observations with the owner, operator, or agent in charge of the device establishment as they are observed, or on a daily basis, to minimize errors and misunderstandings,” says the guidance.  


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Tags: devices, FDA, medical, US

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