A new draft guidance from the US Food and Drug Administration sets performance criteria for magnetic resonance (MR) coils, making the devices eligible for the standards-based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...
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?