FDA to End Alternative Summary Reporting for Devices

Regulatory NewsRegulatory News | 03 May 2019 |  By 

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.

FDA maintains that all alternative summary reporting data since 2017, except for Postmarket Spreadsheet Reports, are currently available in MAUDE.

But FDA data provided to KHN shows that during the first nine months of 2018, FDA continued to accept more than 190,000 injury reports and 45,000 malfunction reports under the alternative reporting program.

FDA also says it has ended the Postmarket Spreadsheet Reports, which were designed for the efficient review of adverse events linked to silicone breast implants.

And device makers will still be able to request certain exemptions or alternatives to reporting requirements.

“By law, a manufacturer may request, under 21 CFR 803.19, an exemption, variance or alternative to reporting requirements under 21 CFR Part 803. These requests will continue to be considered on a case-by-case basis going forward but will include conditions of approval that will ensure availability of data to the public online,” FDA says.


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