The purpose of this document is to provide direction to manufacturers on deciding when to submit a 510(k) for a change to their existing wireless telemetry medical device or to a medical device incorporating wireless telemetry as a feature, as a result of the recent Federal Communication Commission (FCC) rule which designates certain frequency bands as "protected" bands for Wireless Medical Telemetry Service and establishes rules for their use.
www.fda.gov/cdrh/ode/guidance/1073.html
www.fda.gov/cdrh/ode/guidance/1073.html