Statistical Review and Other Developments for New Medical Devices
View Presentation *Gregory Campbell, Food and Drug Administration Keywords: devices, FDA A number of important statistical issues have arisen in medical devices in the past year. Topics from FDA Advisory Committee meetings are highlighted, including 1) the treatment of missing data using tipping point analysis, 2) propensity score methodology in the design and analysis of non-randomized studies, 3) treatment by gender interactions, and 4) benefit-risk for devices to treat obesity. Several FDA guidances have been released including ones on pivotal clinical study design, early feasibility and risk-benefit. A report about the number of submissions FDA receives for medical devices as well as the size of the statistical community in the medical device industry and in FDA’s CDRH.
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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