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FDA Updates Breakthrough Devices Program Guidance The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices that may address health inequities, as well as devices that may offer a non-addictive option to treat pain or …
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FDA Seeks Input on At-Home Use Medical Technologies The FDA Center for Devices and Radiological Health (CDRH) is seeking input from the medical device industry, the public, patient advocacy organizations, healthcare providers and clinical researchers on at-home use medical devices. Expanding access to home use technologies is part of the CDRH’s 2022-2025 Strategic Priority …
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