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Medical Innovation Meets Regulatory Excellence

FDA Cybersecurity Requirements and SBOMs

On March 13, 2024 the FDA released “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act”, which includes clarification on several areas in the September 27, 2023 draft guidance document “Cybersecurity in Medical Devices: Quality System Consideration and Content of Premarket Submission.” In addition, recommendations for cybersecurity documentation in device premarket

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