Performance Criteria Issued On Magnetic Resonance Coils In New FDA Draft Guidance

Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.

Magnetic Resonance Imaging machine operator and a patient -a series of MRI. - Image

A new draft guidance from the US Food and Drug Administration sets performance criteria for magnetic resonance (MR) coils, making the devices eligible for the standards-based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

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