FDA released a final guidance entitled ” Radio-Frequency Wireless Technology in Medical Devices”.

Section 3 addresses design, testing, and use of wireles devices including security, EMC, and maintenance.

Section 4 addresses information to be included in premarket submissions including a description with emphasis on how the design assures timely, reliable, and secure information transfer as well how risks are managed and whether alarm signasl are involved, and whether other products can connect wirelesly to the device. This section also discusses a risk-based approach to V&V, risks associated with security and EMC, test data summaries and labeling of wireless medical devices.

The full guidance is at the link provided.