21 June 2019 - 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 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 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.

Read FDA press release