Performance Criteria Issued On Magnetic Resonance Coils In New FDA Draft Guidance
Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance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.
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In a new final guidance, the US agency has expanded its abbreviated 510(k) program for certain devices to look beyond conformity assessments and instead look at performance criteria. Alongside the guidance, the agency also released four draft guidances for devices it is considering clearing under the new pathway.
A proposed rule from the US agency would move the in vitro diagnostics from high-risk class III to class II with special controls, eliminating the requirement for a PMA.
The International Medical Device Regulators Forum, perhaps most notorious for its efforts to standardize audit processes between nations with its Medical Device Single Audit Program, is also focusing on harmonizing device reviews and adverse event codes.