Radio Experimentation and Market Trials

In this document, the Commission proposes to modify the rules for program experimental licenses to permit experimentation for radio frequency (RF)-based medical devices, if the device being tested is designed to comply with all applicable service rules in Part 18, Industrial, Scientific, and Medical Equipment; Part 95, Personal Radio Services Subpart H--Wireless Medical Telemetry Service; or Part 95, Subpart I--Medical Device Radiocommunication Service. This proposal is designed to establish parity between all qualified medical device manufacturers for conducting basic research and clinical trials with RF-based medical devices as to permissible frequencies of operation.