Performance Criteria for Magnetic Resonance Coils Detailed in FDA Draft Guidance
Posted December 10, 2019
In support of the Food and Drug Administration’s Safety and Performance Based Pathway framework, the agency has specified performance criteria for magnetic resonance (MR) coils in a Dec. 6 draft guidance.
Under the Safety and Performance Based Pathway, makers of MR coils that are planning to submit a 510(k) will have the option to use the performance criteria (as identified in a final guidance document) “to support substantial equivalence, rather than direct comparison of the performance of the subject device to that of a predicate device,” wrote the agency.
In the draft guidance, the FDA recommends that manufacturers “provide a results summary for all tests evaluated in addition to the other submission information” identified for each text or evaluation described in the guidance, in order to “ensure that the performance criteria outlined in this guidance remain contemporary and take into account relevant data from recent clearances.”
The agency provides guidance related to seven MR coil tests:
- Image signal to noise
- Image uniformity
- Surface heating
- Acquired image quality
- Decoupling circuit
- Electromagnetic compatibility (immunity, electrostatic discharge)
- General electrical/mechanical safety
The guidance also provides information related to endpoints that manufacturers should include as part of their biocompatibility evaluation.
The FDA also points out that “test-specific positive, negative, and/or reagent controls should perform as expected, and protocol deviations should be thoroughly described and justified; however, note that certain protocol deviations may invalidate comparison to the performance criteria listed below and require submission of a Traditional, Special, or Abbreviated 510(k).”
Public commenting on the draft guidance is open for 60 days (i.e., until Feb. 7, 2020). Comments can be submitted at www.regulations.gov (docket FDA-2019-D-1650).