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

FDA Hopes To Balance Upfront Time Investment With Easier Reviews In New PMA Program

CDRH Director Jeffrey Shuren hopes that the early, concentrated collaboration that his staff will engage in with manufacturers for select “Expedited Access PMA” devices will make the reviews themselves substantially quicker and easier, he said in an interview.

FDA device center officials hope they can balance the substantial resources that they would need to invest into products accepted into CDRH’s newly proposed “Expedited Access PMA” pathway with a more straightforward, less- intensive review process, but the jury is still out, Center Director Jeffrey Shuren says.

“It may turn out that we spend more resources upfront with an innovator, but actually save some resources later on...

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

More from Policy & Regulation

Cardiology And PTA Procedures In Germany’s Expanded Hybrid DRGs List 2026

 
• By Ashley Yeo

2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.

Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By Elizabeth Orr

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.