miércoles, 11 de enero de 2017

Reminder: FDA Webinar on Postmarket Management of Cybersecurity in Medical Devices Final Guidance

FDA Logo
On January 12, 2017, the FDA will host 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 post-market cybersecurity vulnerabilities for marketed and distributed medical devices by:
  • clarifying the FDA’s recommendations for managing postmarket cybersecurity vulnerabilities;
  • emphasizing that manufacturers should monitor, identify, and address cybersecurity vulnerabilities and exploits as part of their postmarket management of medical devices;
  • establishing a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA; and
  • outlining circumstances in which the FDA does not intend to enforce reporting requirements under 21 CFR, part 806.
We welcome your questions about this final guidance, so please mark your calendars to participate.
Webinar Details:
No registration is required.
  • Date: Thursday, January 12, 2017
  • Time: 1:00 – 2:30 PM EST (To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar)
  • To hear the presentation and ask questions:Dial: 888-972-9334, International Callers Dial: 1-212-547-0198; Passcode: 4663030
  • To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW2170195&p=4663030&t=c
Due to expected high participation of this webinar, please use the following link to access the live presentation if the previous link returns an error message upon logging in: https://www.livemeeting.com/cc/events_vbc1/join?id=PW2170195&role=attend&pw=4663030
Following the webinar, a transcript, audio recording, and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.
Webinar participants must have the WebEx Event Manager installed prior to joining. To download the Event Manager, refer to the instructions on the WebEx Downloads page. If you experience technical difficulties while trying to join the net portion of the call, please dial *0 to reach an operator for technical support, or dial 866-449-0701.
NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.
If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) atDICE@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

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