dr. myzell, welcome. as for you and all witnesses your statements will be made part of the record in their entirety. if you could sum it up in five to seven minutes, i'd be most appreciative. >> thank you, mr. chairman, committee members. good afternoon. thank you very much for the opportunity today to speak about the importance of the medical device safety act of 2009. i am a practicing cardiologist at beth israel deaconess medical center. i direct the medical device safety institute, an independent industry independent ant, nonprofit organization dedicated to improving the safety of medical devices. i served as consultant to fda center for devices in radiologic health since 2003 and previously chaired the fda's poe-market and heart device advisory panels. i hope that you will appreciate that fda marketing clearance or approval of a medical device does not guarantee its safety. in particular, manufacturers' responsibilities for product safety extend well beyond initial fda approval. the u.s. supreme cour

dr. myzell, welcome. as for you and all witnesses your statements will be made part of the record in their entirety. if you could sum it up in five to seven minutes, i'd be most appreciative. >> thank you, mr. chairman, committee members. good afternoon. thank you very much for the opportunity today to speak about the importance of the medical device safety act of 2009. i am a practicing cardiologist at beth israel deaconess medical center. i direct the medical device safety institute, an independent industry independent ant, nonprofit organization dedicated to improving the safety of medical devices. i served as consultant to fda center for devices in radiologic health since 2003 and previously chaired the fda's poe-market and heart device advisory panels. i hope that you will appreciate that fda marketing clearance or approval of a medical device does not guarantee its safety. in particular, manufacturers' responsibilities for product safety extend well beyond initial fda approval. the u.s. supreme cour