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Device Standards Provision In Cures Bill Could Speed Up 510(k) Clearances

Under a provision in the 21st Century Cures bill, which is accelerating towards enactment, FDA may need to consider recognizing more standards, which could speed up review times for 510(k)s. But it is also likely to add a burden for the agency.

A provision in the 21st Century Cures Act addressing FDA adoption of medical device standards could reduce administrative burdens for 510(k) applicants and allow their device to get cleared sooner. But it is also likely to put a bigger burden on FDA.

The legislative language would allow anybody to ask FDA to approve use of nationally and internationally recognized standards, and requires the

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