Emergo by UL launches 510(k) Builder for streamlined US FDA medical device submissions

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RAMS automated FDA 510(k) submission tool minimizes errors to avoid US medical device market entry delays.

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Emergo by UL's 510(k) Builder has been developed to help medical device manufacturers achieve US FDA clearance more cost-effectively and faster.

Emergo by UL, a global medical device and healthcare technology consultancy, has rolled out 510(k) Builder, a new subscription-based software tool to simplify and streamline medical device manufacturers’ FDA 510(k) submissions in order to obtain faster US market access.

Available through Emergo by UL’s Regulatory Affairs Management Suite (RAMS) automated medical device registration and compliance platform, 510(k) Builder provides step-by-step support for preparing and compiling a complete Premarket Notification submission according to FDA requirements.

Key features of 510(k) Builder include:

  • Full integration with FDA databases, allowing users to quickly identify product codes, predicate devices and relevant standards;
  • A “token system” providing auto-population capabilities to ensure consistent application of content throughout a 510(k) premarket submission;
  • Commenting and feedback tools to enable collaboration among staff as the 510(k) is assembled;
  • Automated formatting to meet FDA specifications and reduce submission production time.

FDA 510(k) submission generation typically involves manual preparation and compiling of hundreds of documents; oversights and errors can result in delayed clearance and increased market entry costs for device manufacturers.

“Inconsistencies and omissions in 510(k) premarket submissions can lead to substantial delays for US market applicants, especially when these errors pertain to Indications for Use, product name and related data,” explains Elizabeth Manning, Program Manager at Emergo by UL. “We’ve developed 510(k) Builder to help medical device manufacturers realize more efficient submission generation, plus reduce costly delays in obtaining 510(k) clearance.”

About RAMS
Emergo by UL’s Regulatory Affairs Management Suite (RAMS) software service provides digital tools and insights to help medical device manufacturers monitor regulatory changes, efficiently and cost-effectively prepare FDA 510(k) submissions, and manage device registrations and renewals. Learn more about our automated RA/QA platform at EMERGObyUL.com/RAMS.

About Emergo by UL
EMERGO by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. With a presence on six continents, we can provide real-time service and on-the-ground expertise. Learn more about how we can help you grow at EMERGObyUL.com.

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Stewart Thomas Eisenhart
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