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.
FDA 510(k) submission generation can involve manual preparation and compiling of hundreds of documents; oversights and errors can result in delayed clearance and increased market entry costs for device manufacturers.
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) submission is assembled;
- Automated formatting to meet FDA specifications and reduce submission production time.
“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.”
Emergo by UL’s FDA experts can also provide ad hoc consulting support for users who need help using the tool. This service provides the flexibility to receive as much or as little support as desired with the 510(k) submission, like this customer from ZSX Medical LLC:
“As someone who has never filed a 510(k) before, RAMS 510(k) Builder made the process remarkably straightforward. Our submission was over 900 pages, and I can’t imagine assembling all those documents without 510(k) Builder. Furthermore, we passed the FDA Acceptance Review on our first try.”
510(k) Builder is available as part of the RAMS 2.1 release, which also includes improved interface design and more robust customization options for email notifications. To find more information about the free and premium services offered through RAMS and to sign up for an account, visit 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.
Sponsored content by Emergo by UL