TL10: Statistical Issues in Balancing Pre-market and Post-market Studies for Medical Devices
*Terri Kang Johnson, FDA/CDRH Keywords: post-market study, benefit/risk Under FDA Safety and Innovation Act (FDASIA), emphasis has been shifting from pre-market to post-market in the regulatory setting for medical devices, as long as there is no strong safety concern. Immediate consequences for the pre-market studies may be shorter follow-up time and larger overall type I error rate to name a few. This Roundtable is to offer an opportunity to get together and discuss the statistical implications from this trend: how does this affect the benefit and risk ratio.
|
Key Dates
-
November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC