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FDA discusses regulatory lessons from COVID-19 in town hall discussion

by John W. Mitchell, Senior Correspondent | October 07, 2020
During AdvaMed's 2020 Virtual MedTech Conference, a town hall style session on Tuesday provided a peek into the FDA’s Center for Devices and Radiological Health (CDRH), during which Dr. Jeffrey Shuren and other senior office leaders from CDRH offered an update on CDRH priorities, including the ways in which CDRH is responding to COVID-19.

In a conversation moderated by Janet Trunzo, senior advisor to the president and senior executive vice president for technology and regulatory affairs for AdvaMed, panelists discussed efforts to meet the moment of the COVID-19 pandemic through faster regulatory approval of medical devices and testing.

Dr. Shuren, the director of the CDRH, said the 40-year-old FDA guidelines for approving modern medical devices and other protocols are not vigorous or flexible enough to allow timely market authorization to meet the challenge of the current pandemic. He and the other FDA executives spoke in general terms of their efforts to make the FDA more responsive to developer and manufacturer needs to bring timely products to market more quickly.

In explaining the evolving operating protocols in FDA approval, Dr. Shuren cited two key lessons learned so far in the pandemic that will be critical in an effective response to future pandemics.

The importance of regulatory flexibility. Dr. Shuren provided statistics to demonstrate the FDA's unprecedented workload thus far in 2020. This included reviewing 516 medical devices and 248 reviews, 1,743 pre-Emergency Use Authorizations (EUAs) and 3,040 EUAs, and outreach to more than a thousand manufacturing sites.

Developing better engagement with developers. With a workload that more than doubled in 2020 in response to the pandemic, the FDA shifted staff around to focus efforts on developing COVID-19 treatment devices and tests. This included deploying 58 officers under the auspices of the CDRH with 78 on-site deployments, holding 39 COVID-19-related webinars, and responded to nearly 14 million emails seeking help and clarification.

Dr. Shuren and his staff also spoke of their ongoing efforts to work with and learn from other worldwide regulatory bodies. While there may be differences of opinion from time to time, they stressed the common goal of providing useful information to avoid “regulatory silos” that slow down the introduction of helpful medical devices and testing to the marketplace.

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