Draft Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Draft Guidance for Industry and FDA Staff; Radio-Frequency Wireless Technology in Medical Devices." This draft guidance document addresses issues relevant to the safe and effective use of radio frequency (RF) wireless technology in medical devices, including wireless coexistence, performance, data integrity, security, and electromagnetic compatibility (EMC). These issues involve all stages of the product life cycle and should be considered in preparing premarket submissions; identifying, documenting, and implementing product design requirements, as well as design verification and validation; and risk management processes and procedures.