Yesterday, FDA released a report summarizing its progress on CDRH’s 2016-2017 strategic priorities.
Incorporating “Real-World Evidence.“ FDA reports that it exceeded its goal for using real-world evidence in regulatory decision-making. FDA issued draft guidance to describe how real-world evidence may be used to support pre- and post-market regulatory decisions, and the number of pre-market and post-market regulatory decisions that used real-world evidence increased by 85 percent.
Incorporating Patient Perspective Data. FDA reports that staff interactions with patients were up, and the number of approved IDEs with patient-reported outcomes (PRO) increased by 65 percent. In addition, device sponsors conducted four patient perspective studies (up from zero) in support of pre- and post-market regulatory decisions.
Promoting Quality and Organizational Excellence. FDA reports that it provided on-site quality training and certification examinations, which tripled the number of staff with quality credentials.