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    Health Law Daily Wrap Up, MEDICAL DEVICES—FDA GUIDANCE NOTICES: FDA issues draft guidance for premarket review of robotic surgical systems, (Sep 29, 2026)

    By WK Editorial Staff

    The draft guidance recommends a risk-based approach to premarket review of robotically assisted surgical systems, including expectations for software validation, cybersecurity controls, human factors testing, and clinical or nonclinical evidence demo ...

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