Advance the use of patient reported outcome measures (PROMs) in regulatory decision making
Chul H Ahn, FDA-CDRH  *Xin Fang, CDRH, FDA  Bo Zhang, FDA/CDRH 

Keywords: patient reported outcome, case study, PMA, CDRH

Selected case studies with patient reported outcome measure (PROM) as primary or secondary endpoints in the PMA submissions to FDA\CDRH will be presented. In particular, we will discuss general statistical issues in PROM validation process, followed by the practical issues encountered in the clinical studies where PROMs are used as primary and/or secondary endpoints. We will also summarize the issues surrounding the use of PROM in the medical device clinical studies.