RL22 Can a Postmarket Study be Used to Expand Indications for use of Medical Devices?
*Hesha Duggirala, U.S. Food and Drug Administration 


Post-approval studies (PAS) are used to evaluate device performance and potential device-related problems in a broader population over an extended period of time after premarket establishment of reasonable device safety and effectiveness. Considerable resources are spent in designing these studies. This roundtable will discuss the statistical and regulatory aspects of using PAS to expand indications for marketed devices. Ideas to be discussed include: nesting an investigational device exemption (IDE) study into a PAS; whether nesting can raise the quality of postmarket studies; discussion of whether a nested design is feasible or practical; what would be necessary in designing this study in a way that does not shortchange the IDE process and/or promote off-label use; discuss if a concurrent IDE review at time of post-approval review is possible; and finally what are other methods that could be utilized to broaden indications in the context of a PAS.