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FDA proposes new rules for breakthrough medical devices

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in health care be designated breakthrough products. The agency is also considering expanding its criteria for breakthrough devices to include products that treat rare diseases, as well as non-addictive products to treat pain or addiction.

Both updates were proposed in a recent draft guidance that the federal agency issued. Under the first change, CDRH proposes to broaden the category of devices eligible for breakthrough status to include those that reduce disparities in health in the section on designation requests. Under the second proposal, non-addictive medical products for treating pain or addiction would be considered eligible for breakthrough designation; the change would amend the introduction of the final guidance.

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