A new draft guidance from the US Food and Drug Administration sets performance criteria for magnetic resonance (MR) coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.
The pathway allows specific device types that the FDA believes have an established safety profile to be cleared based on compliance with guidance documents, consensus standards and special controls, eliminating...
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?