USA – FDA to End Alternative Summary Reporting for Devices

In the coming weeks, the US Food and Drug Administration (FDA) will sunset an alternative summary reporting program for medical devices, the agency announced Thursday alongside its notice that textured breast implants would remain on the US market.

“For past data received through summary reporting, the agency will also be making this data, including alternative summary reports for all devices under the program, publicly available in the coming weeks,” the agency said.

And moving forward, breast implant and other device manufacturers will be required to file individual medical device reports that will be publicly available in MAUDE, which is FDA’s database of device-related adverse events.

The decision to end the alternative program follows a recent Kaiser Health News (KHN) investigation that showed how FDA had collected 1.1 million reports through the alternative summary program since 2016…