Emerging From the Pandemic: CDRH In-Person Meeting Status and Premarket Workload
By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and William Maisel, M.D., MPH, Director, Office of Product Evaluation and Quality, CDRH
At the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), we remain committed to fulfilling our mission to protect and promote the public health and to facilitate medical device innovation. Besides the lessons learned responding to an unprecedented pandemic during the last three and a half years, another silver lining to highlight from COVID-19 is the resiliency of the FDA’s staff, their willingness to accept and embrace change, and their unwavering determination to get the work done while setting a “new normal” on how to conduct business in this post-pandemic era. Additionally, we have observed a recent resurgence in device innovation. For example, CDRH has received more submissions for novel devices over the past 12 months than during any 12-month period since we began tracking this metric in 2015.
In-Person Meetings
We are happy to report that in CDRH, we are accepting and holding in-person meetings with stakeholders and have been doing so for quite some time. Part of our commitment to foster medical device innovation has involved—and will always involve—providing industry with predictable, consistent, transparent, and efficient regulatory pathways through meaningful, informative, and productive interactions before and during the submission review process. In addition to in-person meetings, we offer hybrid (some attendees in-person and some virtual) meeting options with medical device sponsors and other stakeholders.
CDRH has been adopting and implementing best practices to make in-person and hybrid meetings as interactive, productive, and effective as possible. Typically, we provide the meeting requestor with a list of expected in-person and remote FDA attendees in advance of all in-person meetings. For requests tied to product submissions, we follow standard scheduling timelines consistent with MDUFA V performance goals. The availability of in-person meetings may be limited by facility capacity and logistical considerations, although it is our intention to accommodate in-person meeting requests wherever feasible.
Update on Premarket Workload
During the pandemic, we communicated on the workload challenges posed by the unprecedented number of submissions related to COVID-19, our implementation of a triage and prioritization approach, and our efforts to return to “normal” review times.
CDRH is pleased to announce that we have been operating under normal review timelines for all incoming premarket submissions for almost a year, and we’re accepting all submission types for review. While we still have fewer than 80 Emergency Use Authorization (EUA) submissions currently under review (mostly for in vitro diagnostic tests for COVID-19), we anticipate a steady workload associated with the transition of devices from EUA to traditional marketing authorization. We have published two guidance documents to help manufacturers that are seeking to transition from EUAs or whose devices fall within certain enforcement policies to market their devices with traditional premarket authorization. So far, more than 30 EUA devices have successfully transitioned to traditional authorization through the 510(k) Premarket Submission pathway or the De Novo pathway. CDRH will continue to keep stakeholders apprised of these transitions as we move forward, along with regular updates addressing our commitment to MDUFA V performance goals.
Innovation Pipeline Appears Robust and Looking Ahead
We remain committed to helping patients in the U.S. gain timely access to high quality, safe and effective medical devices. The COVID-19 pandemic created challenges impacting innovative device development, including impediments to clinical trial enrollment and conduct, delays in completion of non-clinical testing, and reductions in manufacturing productivity. However, as noted above, we are now seeing a resurgence in device innovation, and submissions for novel devices appear robust.
We are excited to embrace this post-pandemic era as a transformative time, where the innovations applied, and lessons learned during the pandemic, will help guide us moving forward and support our mission to protect and promote the public health.
For More Information:
- A Year Into the Pandemic: How the FDA’s Center for Devices and Radiological Health is Prioritizing its Workload and Looking Ahead | FDA
- Looking Ahead to 2022 as FDA’s Center for Devices and Radiological Health Manages a Sustained Increase in Workload | FDA
- FDA’s Center for Devices and Radiological Health’s Continued Efforts to Return to Normal: Reopening for All Pre-Submissions | FDA