Device Good Manufacturing Practice Advisory Committee Meeting

Device Good Manufacturing Practice Advisory Committee Meeting Committee Meeting : April 11, 2013 8:00 a.m. - 6:00 p.m. Agenda: On April 11, 2013, the committee will discuss the potential effects of extreme weather and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality. The committee will further discuss how to optimize the use of FDA’s current regulatory framework to address risks and vulnerabilities to the manufacturing chain resulting from extreme weather conditions. Future steps may be identified to help industry mitigate or better tolerate challenges to the manufacturing chain as a result of extreme weather conditions. In a separate Federal Register notice, FDA is seeking additional broad public input about the effects of extreme weather on medical device safety and quality.