Radiological Devices Panel of the Medical Devices Advisory Committee

Radiological Devices Panel of the Medical Devices Advisory Committee
Committee Meeting April 12, 2012 from 8:00 a.m. – 6:00 p.m. (Day 2 of 2)

Agenda: On April 12, 2012, during session I, the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 (74 FR 16214), for breast transilluminators, one of the remaining preamendments class III devices. On July 18, 1995 (60 FR 36639), FDA published a Final Rule that misbranded breast transilluminators and effectively placed them in class III based on the recommendation of the Obstetrics and Gynecology Devices Panel, which concluded there were no published studies or clinical data demonstrating the safety and effectiveness of this device. The committee discussion will include a review of the present literature to assess the current knowledge of breast transilluminators and determine if sufficient safety and effectiveness data are available to support reclassification of breast transilluminators.

During session II on April 12, 2012, the committee will discuss and make recommendations regarding the classification of blood irradiators. Blood irradiators have been found to be substantially equivalent to predicate devices marketed in interstate commerce prior to May 28, 1976, and are subject to the general controls provisions of the Federal Food, Drug and Cosmetic Act. These devices have never been formally classified. There is an agreement between the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) that outlines which FDA center will regulate these devices. CDRH regulates irradiators intended for use in the immunologically active cells in blood and other tissues and CBER regulates irradiators intended for use in the in-process inactivation of HIV viruses or other pathogens. The committee discussion will focus on whether these devices should be classified in class I, II, or III.