Get our free case study

Guiding 510(k) Preparation and Submission for U.S. Medical Device Market Clearance

From late 2022 continuing through the publication of this case study in mid-2023, The FDA Group has been pleased to support a European biomedical sensor company’s FDA premarket notification via the 510(k) pathway.

This project primarily involved:

  • Identifying, analyzing, and documenting numerous product modifications
  • Redirecting the regulatory strategy from the Special 510(k) to the Traditional 510(k) submission pathway
  • Providing regulatory mentorship and consultancy in navigating the intricacies of submission development

Read our free case study and learn how The FDA Group helped the company catalog, analyze, and precisely classify all device modifications; determine which specific skillsets were necessary to compile the requisite documentation; assign roles to address the extensive documentation needs, and provide guidance in compiling necessary documentation and constructing the 510(k) submission.👇

Get the case study »

Get the Case Study