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

Environmental Group Questions FDA’s Stance On PFAS In Medical Devices

 

The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.

EU4Health Boost For Orphan Devices And SMEs

 
• By 

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Scores Of Companies On Board With Medicare Data Interoperability And Digital Health Initiative

 

The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.

More from Policy & Regulation

Swiss Medtech To Battle ‘Arbitrary’ 39% US Tariff

 
• By 

In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.

Injuries And Deaths Linked To Boston Scientific Cardiac Devices. Company Responds

 

The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.