Enforcement Comeback? FDA Predicts 1,767% Increase In US Inspections In FY ’22, Matching Pre-Pandemic Levels

An FDA budget request released on 28 May estimates that domestic GMP inspections of US device makers will increase from a mere 75 in the current 2021 fiscal year to 1,400 in FY 2022. It also asks for an increase of $18.8m to pay for inspections of all commodities the agency oversees.

Vegetation makes a comeback.

A budget request for the US Food and Drug Administration released by the White House on 28 May predicts that domestic GMP inspections of device makers will increase by a whopping 1,767% in fiscal year 2022.

The FDA estimates it will conduct only 75 inspections in the current fiscal year, which ends on September 30. But...

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

More from Compliance

More from Policy & Regulation

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By 

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By 

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?