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Home » FDA Explains New 510(k) Pathway for Magnetic Resonance Coils
FDA Explains New 510(k) Pathway for Magnetic Resonance Coils
The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison. The guidance applies to sponsors who wish to submit a 510(k) application using the agency’s Safety and Performance Based Pathway.