The safety and performance pathway and de novo clearance process are combining to reform the US Food and Drug Administration’s approach to device approvals, agency officials said on 14 September at RAPS Convergence 2020, hosted by the Regulatory Affairs Professionals Society.
The safety and performance pathway allows some well-understood device types to be cleared for market via compliance with performance criteria, rather than comparisons to a predicate device. The first two...
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
Already a subscriber?