FDA Proposes to Loosen Controls on Shortwave Diathermy Devices

The Food and Drug Administration is proposing to reclassify shortwave diathermy devices (SWD) as Class II devices that do not require premarket approval, in an apparent change in tack on the level of regulation applied to the product. FDA had in 2012 proposed to confirm classification of shortwave diathermy devices in Class III, and would have required the filing of a premarket approval application or product development protocol before distribution. But in response to comments, FDA is now withdrawing its 2012 proposed rule (here), and is instead proposing to reclassify shortwave diathermy devices in Class II (here). The proposal would also rename the device to “nonthermal shortwave therapy (SWT)” devices. Comments are due May 21.