Clinical Studies Needed For Nonthermal Shortwave Diathermy Devices, FDA Panel Says
This article was originally published in The Gray Sheet
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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Chart updating FDA’s progress and decisions in classifying the final set of preamendment devices.
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