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

This article was originally published in The Gray Sheet

Executive Summary

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.

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