FDA Final Guidance For RF Wireless Devices Expands Pre-Market Recommendations-graysheet: FDA highlights its pre-market submission recommendations and design considerations for devices that employ radiofrequency wireless technology in a final guidance document issued Aug. 13. The guidance (PDF) applies to devices that are implanted or worn on the body, or other external wireless medical devices intended for use in hospitals, homes, clinics, clinical laboratories and blood establishments. RF wireless technologies addressed in the guidance include Wireless Medical Telemetry Service, Medical Device Radiocommunication Service, Medical Body Area Network, cellular communication chipsets and RF identification products, according to FDA.
