As part of FDA’s digital transformation, the agency has been modernizing to move away from previously “siloed legacy systems that made it more difficult to do our work,” Shuren described. The goal is a “much more simplified agile platform with data in the cloud.”

Recently launched is the Customer Collaboration Portal, which has an early feature that allows companies to track their 510(k) to see where they are in the process, he said.

“We’ll also start linking in our receipt of electronic submissions as we push toward eStore, and this will eventually become a virtual workspace for us, and industry, and other stakeholders to engage in near or real time in doing our work,” he said. “Ultimately this will be to digitalize our business, our operations, and our activities at CDRH.”