Bayesian methods in the premarket approval of medical devices
View Presentation *Gerry W. Gray, FDA, Center for Devices and Radiological Health Keywords: In May 2006 the FDA Center for Devices and Radiological Health (CDRH) released our draft “Guidance for the use of Bayesian statistics in medical device clinical trials.” The final version of that guidance should be released by the fall of 2009. This talk will discuss the final version of the guidance document, including comments on, and changes from, the previous version. In addition, I will discuss the simulations and sensitivity analyses that we often require for Bayesian submissions and their rationale from the regulatory point of view.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC