FDA Says IEC Standards Sufficient for Ultrasonic Diathermy Devices
The FDA released final guidance that provides policy clarification for ultrasonic diathermy devices as well as information devicemakers should submit in their premarket notification submissions.
Ultrasonic therapy devices are considered both medical devices and electronic products and need to comply with radiation safety performance standards in 21 CFR 1010 and 1050.10 as well as certain International Eletrotechnical Commission (IEC) standards.
The devices produce high-frequency sound waves — transmitted through a wand applied to the skin — that travel deep into tissue to create therapeutic heat to treat pain, muscle spasms and joint contractures.
The FDA said that complying with both FDA and IEC standards can cause manufacturers to duplicate their efforts, and it said that conformance with the IEC standards would provide the same level of protection as the FDA’s performance standards.