ANNOUNCING the FDA Webinar: Design Considerations for Pivotal Clinical Investigations for Medical Devices – Final Guidance Document -- Wednesday, December 4, 2013 – 1:30 p.m. EST
Date: Wednesday, December 4, 2013
Time: 1:30 PM – 3:00 PM (EST)
The webinar will begin promptly at 1:30 PM. We recommend you join at least ten minutes prior to start time to ensure you are included at the beginning of the presentation.
To Participate and ask questions: 888-282-0370, passcode: CDRH
To View the Slide Presentation during the webinar:
https://www.mymeetings.com/nc/join/
Conference number: PW3027867
Audience passcode: CDRH
Participants can also join the event directly at:
https://www.mymeetings.com/nc/join.php?i=PW3027867&p=CDRH&t=c
On November 7, 2013, the FDA released the final guidance document, Design Considerations for Pivotal Clinical Investigations for Medical Devices. This final guidance clarifies the FDA’s thinking on important premarket clinical study design issues and outlines principles and techniques for developing higher quality studies. It complements existing guidance on clinical studies by providing specific examples of different study designs, relevant principles to apply in the choice of study design and techniques for sustaining the quality of clinical studies.
This webinar on December 4th is intended to further clarify the guidance and provide an opportunity to ask questions you may have regarding the guidance document.
We ask that all questions be limited to general questions related to the guidance or to pivotal clinical studies.
Following the conference, a transcript, audio 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.
We look forward to hearing from you on December 4th.
Food and Drug Administration
Center for Devices and Radiological Health
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