US medtech industry association AdvaMed does not think that the Food and Drug Administration's proposal to streamline its de novo process (that is used for innovative, low- to moderate-risk devices that cannot be cleared by the pre-market notification, or 510(k), process) will result in any significant time saving for medtech companies as is being claimed by the agency1,2.
The FDA's proposal, which aims to trim off up to 90 days from the de novo programme, was outlined in...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet 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
Already a subscriber?