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Key Questions Remain Despite FDA Attempts To Clarify Guidance on Clinical Decision Software

Clinical decision support (CDS) software has been recognized — including by government agencies — as having significant potential to increase quality of care and enhance health outcomes, and companies across the health care...more

FDA Proposes Amendments to Medical Device Quality System Regulation

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

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