1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

‘What, Me Worry?’: Experts Say They’re Not Concerned About FDA Restarting Domestic Inspections Amidst COVID-19

 
• By Shawn M. Schmitt

In a few days the US FDA will fire up its domestic inspectorate for the first time since March. But is it a good idea? Three industry experts said during a Food and Drug Law Institute webinar that they’re not particularly worried.

Hand writing on opened notebook with don'??t worry it'??ll be ok words and hand draw smiley, colored filter effect
That's the message from three experts when it comes to FDA inspections

In mere days, on 20 July, the US Food and Drug Administration will fire up its domestic inspectorate for the first time since March, sending investigators back into plants to conduct routine surveillance audits.

But is it a good idea?

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

More from Policy & Regulation

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

‘Small Business’ Applications For Waiver Of Device User Fees To Be Streamlined By US FDA

 
• By Brian Bossetta

FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.

FDA Outlines Responsibilities For Owners Of Transferred 510(k)s

 
• By Elizabeth Orr

The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.