CDRH Looks Forward to a ‘Reset’ for COVID-Delayed Work

By: Randolph Fillmore

January 26, 2021

Categories: AAMI News

The FDA’s Center for Devices and Radiological Health (CDRH) and its priorities were “overwhelmed” and “disrupted” by COVID-19 and the massive increase of work that resulted—but there is hope that the coming year will provide a “reset” for delayed work to begin while still managing the COVID-19 response. That’s according to a December call with Jeffrey Shuren, director of FDA’s Center for Devices and Radiologic Health (CDRH) and Alliance for a Stronger FDA.

COVID-19 “essentially disrupted the trajectory of the medical device program in 2020” delaying much of CDRH’s work while the agency dealt with emergency use authorizations (EUAs) and that the pandemic-related work likely cut down on the number of new technologies aiming for launch in 2020, Shuren said. The “reset” will give CDRH an opportunity to learn from its COVID-19 pandemic experience, as Shuren outlined his hopes, expectations and priorities for 2021 despite the “ripple effect” from COVID-19 related work. These include:

  • Addressing the next round of medical device user fees in MDUFA V
  • Launching programs such as the Safer Technologies Program (STeP)
  • Enhancing the 510(k) premarket clearance pathway
  • Testing a system that would allow companies to track the progress of their submissions
  • Finalizing guidance on clinical decision support software and patient-reported outcomes
  • Expanding the Case for Quality voluntary improvement program
  • Drafting guidance on artificial intelligence and machine learning
  • ISO 13485 alignment and 510(k) modernization

Shuren concluded by saying that they hoped to further manage the COVID-19 work but also move forward with projects unrelated to the pandemic that had to be placed on the “back burner.” However, he noted that 2021 will also be busy as developers seek full marketing approval for COVID-19 devices. He also emphasized addressing MDUFA V as a top priority because those fees that enable FDA to work faster on reviews and authorizations.