FDA’s Regulation of Devices Should Be More Active, Say Academicians

The General Accountability Office (GAO) should press the FDA to stop being passive in its oversight of device safety and instead take a bolder and more active role, according to several academicians who collaborated on an opinion piece in the peer-reviewed healthcare journal Health Affairs.

“GAO could address opportunities to help FDA accelerate its proposed transition from ‘passive’ to ‘active’ safety surveillance,” wrote the academicians in Health Affairs’ Feb. 15 issue.

According to the article in Health Affairs, the FDA primarily relies on passive reporting of device-related adverse events to the Manufacturer and User Facility Device Experience database, with nearly 3 million such reports submitted in 2022. But research and the FDA have documented the flaws of this system, such as underreporting and poor data quality.

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