TL46: Challenges and good practices to improve the quality of therapeutic device submissions
*Manuela Buzoianu, FDA/CDRH 

Keywords: quality, regulatory submission, therapeutic device, data standards

Pre-specification (without any knowledge of the study data) is one essential component to establish statistical significance, if requested, in regulatory submissions. Thus, FDA recommends the sponsor engage in early communication with the agency in pre-submission meetings, during early protocol development stage, and also reach out to the statistical reviewer. These efforts are to produce good quality protocols, particularly detailed adequate analysis plans, and to avoid have incomplete, poorly organized PMA applications. In light of the new MDUFA stringent timelines, we can discuss any challenges that industry and FDA face in preparation/review of the therapeutic device submissions as well as good practices, such as data standardization, to improve the submission quality and the quick interactive review process.