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Regulatory Briefs: FDA Device Reclassifications, Meetings Announcements

FDA proposes class II for nonthermal shortwave therapy devices and updates regulations to reflect class II designation for neuropsychiatric assessment device. Meetings on manufacturing quality, clinical trials and medical countermeasures announced. More regulatory news.

FDA is seeking comments on its Feb. 20 proposed order to down-classify devices currently known as “shortwave diathermy for all other uses” – a pre-amendment class III device – into class II with special controls. FDA also wants to rename the devices “nonthermal shortwave therapy,” because they do not heat body tissues the way thermal shortwave diathermy devices do. If the order is finalized, manufacturers would have to submit a 510(k) within 60 days of the effective date of the final order.

In 2012, the agency proposed requiring PMAs for the devices. (See Also see "Regulatory News In Brief" - Medtech...

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