CLSA & BCG Release Report on FDA Medical Device Regulatory Trends

Nov. 5, 2015

Developed in collaboration with The Boston Consulting Group, with input and cooperation from the FDA, California Life Sciences Association (CLSA) last month released a report, “Recent Trends in FDA Medical Device Regulation,” utilizing the FDA’s publicly available data to evaluate FDA’s regulatory review processes for medical devices. The report examines premarket approval (PMA) review times, 510(k) decision times, and variations in performance across the FDA’s Center for Device and Radiological Health (CDRH) review divisions and branches. It serves as a follow-up to last year’s report, “Taking the Pulse of Medical Device Regulation & Innovation.”

Key findings of this year’s report include:

  • PMA: After a decade-long trend upwards, PMA review times have improved markedly over the past few years, with the considerable exception of 2013. One factor that may have contributed to the slowdown in 2013 was an increase in the percentage of devices referred for panel review — jumping from 8 percent in 2012 to 36 percent in 2013, a near record.
  • 510(k): The latest data show the first signs of improvement for 510(k) products, the bulk of devices reviewed by the FDA. After plateauing at the turn of the decade, clearance times, though still far above historic averages, have shown recent decreases suggesting that they may be turning the corner.
  • Comparing Divisions: Over the years, there have been significant variations in performance across CDRH review divisions and branches. Fortunately, the data suggests recent overall performance improvements have also resulted in more consistent performance across the system.

The report has been distributed to members of our California Congressional Delegation, congressional leadership, key lawmakers on congressional committees of jurisdiction, sector stakeholders, and with FDA leadership and staff. We intend for it to guide policymakers in implementing policies that will strengthen Agency performance in both the 21st Century Cures (House) and Innovation for Healthier Americans (Senate) initiatives, as well as the Medical Device User Fee Act (MDUFA) reauthorization bill to be considered in the 115th Congress.

Click here to view the report. Click here to view the report press release.

For questions, please contact Jenny Carey, CLSA’s Director of Federal Government Relations and Alliance Development (