Statement from Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, on agency’s efforts to increase transparency in medical device reporting

Statement from Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, on agency’s efforts to increase transparency in medical device reporting 

In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these products. First, we have formally ended the Alternative Summary Reporting (ASR) Program. Under this program, manufacturers of certain devices could request an exemption from the requirement to file individual medical device reports for certain events that were well-known and well-established risks associated with a particular device and to instead submit quarterly summary reports of such events. Since the program’s inception in 1997, the FDA granted 108 such exemptions to individual manufacturers for certain well-known events associated with specific devices, which were often already described in the product labeling available to...

Read More