1. Medtech Insight

FDA Extends Parallel Review Program ‘Indefinitely’

 
• By Elizabeth Orr

The program, which allows select manufacturers to have their products reviewed simultaneously for FDA approval and Medicare coverage, has been in the pilot stage since 2011. Now it is formally in full implementation mode and the agencies are looking for more manufacturers to participate.

A program that allows medical device sponsors to pursue FDA approval and Medicare coverage simultaneously is being “fully implemented and extended indefinitely” after a five-year pilot period, FDA announced in an Oct. 24 Federal Register notice. The notice states that CMS and FDA are actively looking for innovative products that might be eligible for the parallel review program, which is designed to reduce the time between when FDA grants PMA approval or a de novo classification and when Medicare issues a national coverage determination. This, the agencies hope, will improve outcomes by allowing patients to access new technologies more quickly.

FDA and CMS announced plans for the parallel review pilot program on Sept. 17, 2010. The agencies began recruiting companies for a pilot program on Oct. 11, 2011, and announced a two-year pilot program extension on Dec. 18, 2013

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 Policy & Regulation

More from Medtech Insight

Synchron And Apple Team Up To Use ‘Mind-Thought Connection’ To Control iPhones, iPads

 
• By Marion Webb

Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.

Abbott’s FreeStyle Libre CGM Reduces Cardiovascular Disease-Related Hospitalization

 
• By Natasha Barrow

The REFLECT studies showed a 78% reduction in cardiovascular disease-related hospitalization for people living with type 1 diabetes with prior low blood sugar episodes.

A Deregulated Medtech Sector Could Flourish In Merz’s Industry-Friendly Germany

 
• By Ashley Yeo

Less bureaucracy, no more national supply chain law, framework agreements and competition for direct reimbursement of medtech innovations are among the positive changes the local medtech industry might expect as Germany’s new government gets down to work. Life sciences lawyer Gunnar Sachs offers a view from the ground.