Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Extends On-Site Surveillance Inspections Freeze Another 2 Weeks Because Of Omicron

Executive Summary

The US agency had previously decided to halt domestic inspections through at least 19 January because of the COVID-19 Omicron variant. But now that timeline has been lengthened.

The US Food and Drug Administration won’t be conducting on-site domestic surveillance inspections for another two weeks at a minimum, the agency announced on 21 January.

The FDA  decided on 29 December to halt inspections through at least 19 January because of the COVID-19 Omicron variant. But now that timeline has been lengthened. (Also see "Here We Go Again: Omicron Forces FDA To Pause ‘Certain Inspectional Activities’" - Medtech Insight, 5 Jan, 2022.)

“The FDA is extending the pause on domestic surveillance inspections through Feb. 4 with the goal of restarting these activities as soon as safely possible,” the agency said on 21 January, noting that it will proceed with foreign inspections that have already been planned and cleared by the host countries.

The FDA says it decided on 18 January to keep its inspections freeze in place.

“The agency continues to conduct both foreign and domestic mission-critical inspections … leveraging a variety of tools, including remote assessments and import operations surveillance,” the FDA said.

“When will FDA get back to live foreign inspections? The real question is whether FDA will ever get back to those inspections.” – Steve Silverman

Further, the agency had planned to begin scheduling overseas inspections in February but now that won’t happen for a few more months.

“The FDA’s goal is to return to a regular cadence for foreign surveillance inspections in April,” the agency said.

That the FDA hasn’t conducted a foreign surveillance inspection since early 2020 is troubling to Steve Silverman, a former director of the FDA device center’s compliance office.

“I’m really skeptical about the return of in-person foreign inspections,” he said on the 20 January episode of Medtech Insight’s podcast series Speaking Of Medtech.

“It’s 2022 and we’ve seen more than two years of sidelined foreign inspections. And there’s no end in sight,” said Silverman, who’s now head of The Silverman Group consulting firm. “When will FDA get back to live foreign inspections? The real question is whether FDA will ever get back to those inspections.”

Listen to Silverman’s full comments on the FDA’s inspections predicament – and much more – in the Speaking Of Medtech podcast below:

Related Content

Topics

UsernamePublicRestriction

Register

MT144974

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel