Webinar-Postmarket Management of Cybersecurity in Medical Devices-Final Guidance-January 12 2017
U.S. Food and Drug Administration. (2017). Webinar-Postmarket Management of Cybersecurity in Medical Devices-Final Guidance-January 12, 2017.
This webinar sponsored by the U.S. Food and Drug Administration (FDA): clarified recommendations for managing postmarket cybersecurity vulnerabilities; emphasized the importance of monitoring, identifying, and addressing cybersecurity vulnerabilities and attacks on a continual basis; highlighted the importance of establishing a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA; and outlined circumstances in which the FDA does not intend to enforce reporting requirements under 21 CFR, part 806.