CDRH Industry: REMINDER; FDA Webinar, "Content of Premarket Submission for Management of Cybersecurity in Medical Devices” [October 29, 2014]

***R E M I N D E R****

FDA Webinar

“Content of Premarket Submission for Management of Cybersecurity in Medical Devices”

Wednesday October 29, 2014

2:00 PM – 3:30 PM, Eastern Time
To ensure you are connected, log-in by 1:45 PM.

On October 1, 2014, the Food and Drug Administration (FDA) issued a final guidance document, “Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”  This guidance identifies issues related to cybersecurity that manufacturers should consider in the design and development of medical devices and in preparing premarket submissions.

The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected devices, and the frequent electronic exchange of medical device-related health information.

This guidance applies to premarket medical device submissions received beginning October 1, 2014.

Tomorrow, October 29, 2014, the FDA will hold a webinar to explain the guidance and to provide a forum for asking questions you may have.  Registration is not necessary.  

Webinar Details:

Date:  Wednesday, October 29, 2014
Time: 2:00 PM – 3:30 PM, Eastern Time
To ensure you are connected, log-in by 1:45 PM.

To hear the presentation and ask questions:
Dial: 888-456-0356; passcode:  9748303

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join/
Conference number: PW8952921
Passcode: 9748303

Following the webinar, a transcript, recording and slides will be available at:
http://www.fda.gov/Training/CDRHLearn/default.htm

Please Note: the slide presentation will also be available at this site on the morning of the webinar.

If you have questions/concerns, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov.