1. Medtech Insight
  2. >>Policy & Regulation

Shuren At FDLI: Least-Burdensome, Real-World Evidence Efforts Picking Up

 
• By Elizabeth Orr

US FDA's device-center head discussed his continued push to make regulations more flexible, plans for least-burdensome training and what's next for NEST, among other topics, at the Food & Drug Law Institute annual gathering in Washington DC.

US FDA’s relatively slow path to market may cost small manufacturers more than $40m more than they’d spend in countries with easier device approvals, device-center head Jeffrey Shuren acknowledged at the Food & Drug Law Institute’s Annual Conference May 4 in Washington, DC.

The figure, which was compiled by Versant Ventures, includes $1.8m for eight extra weeks waiting to meet with FDA; $5.5m for a six-month animal study; $10.8m for a year spent...

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

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.