FDA regulation of clinical high intensity focused ultrasound (HIFU) devices

摘要: In the U. S., medical devices are regulated under authority of 1976 Medical Device Amendments to Food, Drug, and Cosmetic Act, with Food Drug Administration's Center for Devices Radiological Health having primary responsibility. The Act defines several regulatory paths market depending on complexity device indications use. For most high intensity focused ultrasound (HIFU) premarket submissions include both pre-clinical clinical data. Pre-clinical testing generally comprises power measurements field characterization, in vitro vivo temperature measurements, thermal computational modeling, demonstrating accuracy targeting region interest monitoring treatment progress. Protocols trials developed by sponsor conjunction FDA scientific staff. Currently there no recognized guidance or standards documents HIFU that could be used review process, but such work is underway within International Electrotechnical Commission.