Proposed Changes to FDA Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: What you Should Know
HL Chronicle of Data Protection
OCTOBER 25, 2018
The new draft premarket cybersecurity guidance provides information designed to aid manufacturers in determining how to meet the agency’s expectations during premarket review of medical devices. October is National Cybersecurity Awareness Month and the Food and Drug Administration (FDA or the agency) has been busy.
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