Tag Archives: cybersecurity

FDA Guidance on Cybersecurity in Medical Devices

On December 28, 2016, the Food and Drug Administration (FDA) issued guidance on Postmarket Management of Cybersecurity in Medical Devices. The guidance clarified aspects of the reporting requirements under Part 806 (21 CFR part 806), which require device manufacturers and importers to report certain device corrections and removals to the FDA. Most actions taken by manufacturers to address cybersecurity vulnerabilities and exploits are considered “routine updates and patches” that do not require advance notification or reporting. However, actions taken by manufacturers to correct device cybersecurity vulnerabilities and exploits that

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