The FDA Releases New Draft Guidance on Considering Health Care Disparities When Reviewing Proposed Devices
C&M Health Law
NOVEMBER 3, 2022
Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). If this latest draft guidance is finalized after a period of public comment, the agency will incorporate the proposed language into the 2018 guidance.
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