Magnetic resonance diagnostic device; panel recommendation and report on petitions for magnetic resonance reclassification and codification of reclassification--FDA. Final rule.
The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to a petitioner reclassifying the magnetic resonance diagnostic device, from class III (premarket approval) into class II (performance standards). The order is being codified in the Code of Federal Regulations as specified herein.
D002965:Classification; D007221:Industry; D008279:Magnetic Resonance Imaging / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration