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Clinical Studies Needed For Nonthermal Shortwave Diathermy Devices, FDA Panel Says

The Orthopaedic and Rehabilitation Advisory Panel recommended FDA require a randomized, sham-control study design with a well-defined patient population to prove safety and effectiveness for the devices. The agency is currently considering whether to retain the preamendments device category in class III or downclassify to class II.

An FDA panel recommended that manufacturers of nonthermal shortwave diathermy devices (SWDs) sponsor clinical performance studies to support safety and effectiveness of the devices, even though there is no clear risk of injury with the devices.

Specifically, the Orthopaedic and Rehabilitation Advisory Panel recommended a randomized, sham-control study design with a well-defined patient population at its...

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