MR Coils: FDA Details Safety and Performance Based Pathway Criteria
The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing the performance criteria and testing methodologies device makers can use to support a 510(k) submission for magnetic resonance (MR) coils under the agency’s safety and performance based pathway.Background
Earlier this year, FDA finalized guidance explaining its new safety and performance based pathway, which allows device makers to seek 510(k) clearance for certain devices based on performance criteria and voluntary consensus standards rather than direct comparison testing to predicate devices.
In September, FDA updated the final guidance and issued the first four draft guidances setting performance criteria for specific Class II devices under the safety and performance based pathway.
MR Coils: Performance Criteria
Within the eight-page draft guidance, FDA explains that its recommendations only apply to MR coils regulated under 21 CFR 892.1000 with the product code MOS intended to produce images of human anatomy for general diagnostic use by trained clinicians and that MR coils with specific clinical indications or intended for use with imaging agents are out of scope.
Additionally, FDA explains that the draft guidance only applies to air-cooled and receive-only radiofrequency coils.
FDA also notes that it may determine that it needs to review additional data before determining whether a device is appropriate for the safety and performance based pathway and says that if a device maker determines that additional testing beyond what is laid out in the guidance is necessary that the company should contact the agency during the pre-submission phase.
For MR coils that qualify for the safety and performance based pathway, FDA sets out seven performance tests, as well as their respective methodologies and performance criteria, that device makers should conduct and include in their 510(k) submissions.
The seven tests include image signal to noise (SNR); image uniformity; surface heating; acquired image quality; decoupling circuit; EMC – immunity, electrostatic discharge; and general electrical/mechanical safety.
The draft guidance also includes considerations for whether or not biocompatibility testing should be conducted based on the design of the device.
FDA