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. This is the first time that FDA has been clear as to its expectation that it be created by manufacturers and provided to customers.
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