Warning Letter Roundup & Recap – January 2023

The US Food and Drug Administration published three device-related warning letters in January – two that went to divisions of endoscope vendor Olympus, and one to a Maryland vision treatment firm.

Warning Rubber Stamp

Check out Medtech Insight's US FDA Warning Letter Data Tracker here.

This chart lists device-related warning letters released by the US Food and Drug Administration in January 2022. If an inspection...

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 Regulation

More from Policy & Regulation

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

From Imitation To Action: Johns Hopkins Robot Autonomously Performs Key Step In Gallbladder Surgery

 
• By 

Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.