The US Food and Drug Administration is postponing foreign inspections including for medical device manufacturing facilities through at least April 2020 as multiple countries grapple with the COVID-19 pandemic.
The FDA move takes immediate effect, and applies to all foreign inspection activities save those considered “mission-critical” by the agency.
For medical device manufacturers based outside the US and dependent on FDA inspections to obtain US market registration, this announcement may mean delays in premarket application reviews. Furthermore, because the agency may conduct 21 CFR Part 820 quality system inspections at random as well as on a pre-announced basis, so some companies may not yet know if or how the postponement may affect them.
FDA states that in lieu of physical device and manufacturing facility inspections, alternative methods will be utilized, including:
- Denial of entry of unsafe products into the US;
- Physical examinations and sampling of devices at US borders prior to importation;
- Reviewing device manufacturers’ previous compliance histories;
- Requesting records and documentation in advance or instead of on-site inspections
Emergo by UL will keep abreast of the situation and report on when FDA resumes foreign medical device manufacturer inspections, as well as whether and when additional medical device and IVD market regulators adopt similar policies.
Related US FDA medical device regulatory resources from Emergo by UL:
- US FDA QSR quality management system (21 CFR Part 820) compliance consulting
- FDA 510(k) premarket notification consulting for medical device companies
- Whitepaper: What to expect during an FDA QSR inspection
- Whitepaper: Preparing a US FDA 510(k) submission