Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Committee Meeting April 5, 2013 8:00 a.m. - 6:00 p.m. Agenda: On April 5, 2013, the committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. On July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make Shortwave Diathermy devices Class III, requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act 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.