CDRH Industry: REMINDER: Webinar on Adaptive Designs for Medical Device Clinical Studies Final Guidance

On July 27, 2016, the FDA published the Adaptive Designs for Medical Device Clinical Studies Final Guidance.  It provides clarity on how to plan and implement adaptive designs for clinical studies used in medical device development.   

FDA will discuss this final guidance document at a webinar scheduled on Thursday September 22, 2016. The webinar is intended to help manufacturers and other interested stakeholders understand the information provided in this final guidance document.   Following a brief presentation, the FDA will respond to questions.

Webinar details:

Registration is not necessary.

• Date:  Thursday, September 22, 2016
• Time: 12:00 PM – 1:30 PM ET
• To hear the presentation and ask questions:
• Dial: 888-456-0327; passcode: 8872340
• International: 1-312-470-0074; passcode: 8872340;
• Conference number: PW9776689
• To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PW9776689&p=8872340&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_vbc2/join?id=PW9776689&role=attend&pw=8872340

Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will be available at this site on the morning of the webinar.

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

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health