1. Medtech Insight

Duodenoscope-Makers Ordered By FDA To Conduct Sec. 522 Postmarket Surveillance Studies

FDA orders three duodenoscope manufacturers – Olympus America, Fujifilm Medical Systems and Hoya Corp.'s Pentax Life Care Division – to conduct postmarket surveillance studies to better understand how the scopes are being reprocessed and how to reduce the risk of patient infection. The firms told "The Gray Sheet" that they will comply with the agency's request.

Three manufacturers of duodenoscopes associated with contamination incidents over the past three years must conduct postmarket surveillance studies so FDA can evaluate how the devices are being reprocessed between procedures and determine how best to reduce infection risks, the agency ordered on Oct. 5.

Under the order, Olympus America, Inc., Fujifilm Medical Systems USA Inc. and Hoya Corp

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 Compliance

More from Policy & Regulation

Beyond The Bladder: Incontinence Impacts Mental Health

 
• By Brian Bossetta

In recognition of Mental Health Awareness month, Sarah Jenkins, executive director at the National Association for Continence, discussed the mental health issues that often come with incontinence.

AI Rollout Aims To Accelerate FDA’s Product Review Process

 
• By Elizabeth Orr

The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.

Access To Library Tools Being Restored At US FDA

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.