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

Are You On The List? FDA ID’s Devices That Might See Less Premarket Data Or Downclassification

CDRH says it exceeded its goal to retrospectively review half of all pre-2010 PMA device types. So far, 21 categories have been slated as candidates for downclassification and another 21 may be tagged for shifting some data requirements to the postmarket.

FDA’s device center has proposed premarket data shortcuts for 21 PMA device types ranging from silicone breast implants to catheter ablation systems to more than a dozen in vitro diagnostic systems in one fell swoop. At the same time, CDRH has identified another 21 PMA categories that might be able to be downclassified from class III to class II.

This comes into response to a pledge the center made in early 2014 as part of an overall priority to...

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

EU Digital Omnibus Meets MDR And IVDR Revisions: Alignment Or Chaos?

 
• By Amanda Maxwell

Simultaneous revisions of the EU’s AI, data and medtech rules offer opportunities for simplification and alignment but also risk confusion and competing priorities. With political tensions in the background, does all this portend further unwanted compromises or delays for medtech?

Long-Awaited EUDAMED Notice Ushers In New Era Of Compliance

 
• By Amanda Maxwell

After years of delays - and even skepticism in Rome last month when officials hinted at its imminent debut - the long-awaited EUDAMED medical device database release has finally been confirmed

Proposed Revision Of Digital Rules – EU’s Good Start But Medtech Advises Caution

 
• By Amanda Maxwell

The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?

Hundreds Of Adverse Events, Multiple Deaths, Associated With Abbott Correction Of Libre 3 Sensors

 
• By Brian Bossetta

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.

More from Policy & Regulation

Hundreds Of Adverse Events, Multiple Deaths, Associated With Abbott Correction Of Libre 3 Sensors

 
• By Brian Bossetta

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.

LDTs Aimed At Catching Cancers Early Hold Promise In Reducing Late-Stage Diagnoses, Study Shows

 
• By Brian Bossetta

A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.

How The EU’s Digital Omnibus Package Could Provide Breathing Space For Medtech

 
• By Amanda Maxwell

The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.