Device Safety Reforms: What’s in the Conversation?

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With user fee reauthorization anticipated in 2022, consumer and public health advocates are pushing for reforms to tighten up FDA’s device oversight, including in the 510(k) and postmarket arenas. Here are some potential reforms they have raised for consideration.

Congress will be paying extra attention to FDA policies in 2022 and, among other things, that could mean consideration of device safety reforms.

The imperative to reauthorize user fees by September 30 will sharpen lawmakers’ focus on FDA operations and changes they want to make. That emphasis will be augmented by efforts to legislate a response to pandemic response shortfalls, and innovation-directed initiatives like the Biden administration’s recently announced Cancer Moonshot and the Cures 2.0 legislation

On the one hand, the legislative activity provides a chance for industry and FDA to shore up resources and priorities and to advocate for bigger reforms. But consumer and public health advocates also have an opening to press for tighter premarket requirements and more robust postmarket safety surveillance for devices to address what they see as significant gaps in FDA’s device oversight.


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