FDA Proposes New Premarket Approval For Some SWD Devices

Law360, New York (July 5, 2012, 7:13 PM EDT) -- The U.S. Food and Drug Administration may soon require that certain shortwave diathermy devices undergo a costlier approval process, according to a notice to be published in the Federal Register on Friday.

The proposed rule covers SWD devices that use electromagnetic energy in radio frequency bands to treat medical conditions other than malignancies through means other than heat, according to the notice. The FDA wants to require the filing of a premarket approval application or a notice of completion of a product development protocol for those...
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