ABSTRACT
Approval ....................................................................................................302 24.3 Special Considerations for Use of MRCT Data for Medical
Device Applications .................................................................................303 24.4 Statistical Design and Analysis of Medical Device MRCTs for
Regulatory Decision Making .................................................................305 24.4.1 Features of a Typical Medical Device MRCT .........................305 24.4.2 Current Practice ..........................................................................305 24.4.3 New Development-Looking Forward ..................................306
