viernes, 2 de septiembre de 2016

CDRH Industry: Adaptive Designs for Medical Device Clinical Studies Final Guidance – FDA Webinar on September 22, 2016

FDA Logo
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.  This final guidance applies to premarket medical device submissions including premarket approval applications (PMA), premarket notification (510(k)) submissions, de novo submissions, humanitarian device exemption (HDE) applications, and investigational device exemption (IDE) submissions.  The Agency encourages companies to consider the use of adaptive design in their clinical trials.  
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:
Following the webinar, a transcript, recording and slides will be available at: 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), 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health

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