Subscribe
Get our free email newsletter

Subscribe / Renew

Breakthrough Devices Program

FDA Updates Metrics for Breakthrough Devices Program

New FDA data shows more than 1200 medical devices have now been granted Breakthrough Device designation. With 164 approvals in fiscal year 2025 and continued strong activity across CDRH and CBER, the program remains a key pathway for accelerating innovative medical technologies.

Digital Sponsors

Become a Sponsor

Discover new products, review technical whitepapers, read the latest compliance news, and check out trending engineering news.

Get our email updates

What's New

- From Our Sponsors -

Don't Let Regulations

Derail Your Designs

Get free access to:

Close the CTA
  • Expert analysis of emerging standards
  • EMC and product safety technical guidance
  • Real-world compliance solutions

Trusted by 30,000+ engineering professionals

Sign up for the In Compliance Email Newsletter

Discover new products, review technical whitepapers, read the latest compliance news, and trending engineering news.

Close the CTA