Feb 3, 2020

Emergo by UL has launched 510(k) Builder, a new software tool supporting streamlined generation of US FDA medical device premarket submissions.

A new subscription service offering available via Emergo’s Regulatory Affairs Management Suite (RAMS) digital RA/QA platform, 510(k) Builder enables fewer FDA 510(k) submission errors, faster regulatory review timeframes and fewer US market entry delays.

510(k) Builder features full integration with FDA databases so that users can quickly identify necessary data such as product codes and predicate devices; auto-population capabilities to ensure consistent content throughout manufacturers’ submissions; and automated formatting of documentation according to FDA requirements.

Learn more about how 510(k) Builder can provide more cost-effective and efficient FDA premarket submission development via our press release.


  • Stewart Eisenhart