Emergo by UL, a global medical device and healthcare technology consultancy, rolled out 510(k) Builder, a subscription-based software tool to streamline medical device manufacturers’ FDA 510(k) submissions.
Available through Emergo by UL’s Regulatory Affairs Management Suite (RAMS) automated medical device registration and compliance platform, 510(k) Builder includes:
- Full integration with FDA databases, supporting quick identification of product codes, predicate devices and relevant standards
- A “token system” providing auto-population capabilities to ensure consistent application of content throughout a 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
The tool is intended to address the potential for oversights and errors that arise from manual preparation and compiling of hundreds of documents.
“Inconsistencies and omissions in 510(k) premarket submissions can lead to substantial delays for U.S. market applicants, especially when these errors pertain to Indications for Use, product name and related data,” said 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.”