FDA released a report, authored by Booz Allen Hamilton, on the state of a series of FDA CDRH initiatives to improve the process of medical device review under the user fees act. With many of the initiatives focusing on communication, transparency and process clarity, the report was able to observe some significant procedural improvements since the effort was launched in 2014.
Reviewing a cohort of over 9,000 traditional 510(k)s filed between FY2015 and FY2017, the authors reported the following:
- First-cycle refusal-to-accept decisions decreased from 38.9% in FY2015 (before the implementation of a new checklist) to 32.7% in FY2017.
Traditional 510(k)s accepted on the first cycle increased from 64% in FY2015 to 71% in FY201.
- The 510(k) submission withdrawal rate remained steady between FY2015 and FY2017 at around 6%.
Reviewers are communicating more with sponsors. In FY2015, the average number of interactions was 3.8 rounds per submission, which increased slightly to an average of 4.8 rounds per submission in FY2017.
- CDRH is meeting review timelines under the MDUFA guidelines. Of the 7,558 510(k) submissions in the analyzed cohort with available MDUFA decisions, only 174 (2%) missed the agency’s goal of providing a decision within 90 days.
In addition to their data analysis, Booz Allen Hamilton provided some additional recommendations for future improvements concerning document control, staff training, submission sub-process management and decision quality management, among other opportunities.