Lifting the Curtain on Alternate Summary Reports

All ASR data files going back to 1999 are now available on FDA’s website. It is a large data set with over a million individual reports of device related injuries and malfunctions. We have started looking into this data and plan to provide insights that will help all of us better understand this information.

Risk ManagementNaveen AgarwalJuly 15, 2019Alternate Summary Reports, ASR Program, ASR program data, FDA ends ASR, Summary reports, medical device, medical device reportsComment