Medical Devices

Webinar - Postmarket Management of Cybersecurity in Medical Devices Final Guidance - January 12, 2017

         

On January 12, 2017, the FDA hosted a webinar for industry to review, discuss and answer questions regarding the "Postmarket Management of Cybersecurity in Medical Devices Final Guidance” document.

This final guidance will inform industry of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices by:

  1. clarifying the FDA’s recommendations for managing postmarket cybersecurity vulnerabilities;
  2. emphasizing that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of their postmarket management of medical devices;
  3. establishing a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA; and
  4. outlining circumstances in which the FDA does not intend to enforce reporting requirements under 21 CFR, part 806.

Target Audience: Industry

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health

Page Last Updated: 09/12/2018
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