WASHINGTON — The Food and Drug Administration is working with nine heath companies to learn more about medical software development so that the agency can consider allowing companies to sell software with less, or perhaps, no evaluation of the software itself before it goes to market, the agency announced Tuesday.

The nine companies, whose products range from fitness trackers to diagnostic test development, are helping the FDA develop a pre-certification program, dubbed “FDA Pre-cert,” which would shift the agency’s focus from evaluating products to evaluating producers. If a company demonstrates that it meets certain to-be-determined markers of quality, then it could be subject to less regulation.

Unlock this article by subscribing to STAT Plus today. Try it FREE for 30 days and cancel anytime!

SUBSCRIBE TODAY

What is it?

STAT Plus is a premium subscription that delivers daily market-moving biopharma coverage and in-depth science reporting from a team with decades of industry experience.

What's included?

  • Authoritative biopharma coverage and analysis, interviews with industry pioneers, policy analysis, and first looks at cutting edge laboratories and early stage research
  • Subscriber-only networking events and panel discussions across the country
  • Monthly subscriber-only live chats with our reporters and experts in the field
  • Discounted tickets to industry events and early-bird access to industry reports

Sign up for our Morning Rounds newsletter

Your daily dose of what’s new in health and medicine.

Privacy Policy