Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff." This guidance document is intended to assist industry and FDA staff in identifying and appropriately addressing specific considerations related to the incorporation and integration of radio frequency (RF) wireless technology in medical devices. This guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility, and provides recommendations for information to be included in FDA premarket submissions for such devices.