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Panel to Discuss Shortwave Diathermy Device Reclassification

11/29/2012

Federal Register Notice: FDA’s Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee will meet 4/5/13, from 8 a.m. to 6 p.m. at the Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD. The committee will discuss and make recommendations on the possible reclassification of shortwave diathermy devices. On 7/16, FDA issued a proposed rule which, if made final, would make shortwave diathermy devices Class 3, requiring premarket approval. FDA has received petitions in response to the proposed rule under FDCA 515(b)(2)(B) requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2012-N-0378. Contact Jamie Waterhouse, (301) 796-3063. To view this notice, click here.

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