> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Shuren Advocates for More Regulatory Flexibility Post Covid
- URL: https://www.fdaweb.com/shuren-advocates-for-more-regulatory-flexibility-post-covid/
- Published: 2022-06-06T12:00:00.000Z
- Updated: 2026-09-14T17:47:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151980

CDRH director **Jeff Shuren** says as the Covid-19 health emergency subsides he hopes the Center can incorporate more regulatory flexibility, which was critical in getting numerous products to market during the public health emergency. He said this during an online FDA update about life after the pandemic and what procedures from the pandemic can be carried over as the agency transitions back to a more normal workaday process. 

Shuren said the Emergency Use Authorization (EUA) authorities gave the agency the ability to tailor the regulatory pathway to much better align with technology and it allowed the regulators to be agile and rapidly adapt as needed. He said FDA officials have been big proponents of having those capabilities in what he described as the post-Covid “peacetime,” without also changing CDRH’s reasonable assurance of safety and effectiveness standard. 

Before this flexibility was forced on the agency, Shuren said, the variations in device technology made it sometimes difficult to use the standard “cookie cutter pathways. And we’re seeing those challenges arise with some of the more modern technologies, such as many of the digital health technologies that come our way. And so the only way to solve this is to change U.S. law to give us that flexibility.” The flexibility is something that not only he personally believes is important but something agency leaders have talked about for years, which he called “agile regulation, or this idea of regulatory Legos where you can really build pathways and tailor them. If we don’t do this, I do foresee challenges for many modern technologies in the U.S. marketplace moving forward.” 

Shuren also said he would like to see the Center continue with the “extensive engagement” exercised during the pandemic with device developers, but this is very resource-intensive. This engagement could be modeled from the pre-EUA process “where developers could work with our reviewers to get their questions answered and problems solve in real or near real time. He said he was excited that in the next user fee program, which begins 10/1, CDRH will have resources to at least pilot this approach. Additionally, he said he would like to see the Center continue with its process of quickly issuing guidance documents.