Folio Consulting Group has helped clients prepare and submit countless Pre-Submissions to FDA.

A FDA Pre-Submissions will help you introduce your medical device to FDA and align on the regulatory pathway and performance testing requirements.

To help you complete your FDA Pre-Submission and make sure you include all the information FDA needs to have a productive meeting, this item is a detailed FDA Pre-Submission template. The template will include links to relevant FDA guidance documents and a description of what information should be included in each section.

This template it geared towards a Class II 510(k) device, with an identified predicate. If you need support for a Class III device - please reach out to Folio Consulting Group for assistance with your regulatory strategy.

The Pre-Submission is provided as a .doc in word format for you to immediately start to edit and use as your submission foundation. Once your team has completed the Pre-Submission, reach out to Folio Consulting Group for support reviewing the document and offering any additional regulatory advise to ensure productive feedback from the FDA. 

Customers will receive a link to download their digital file in the thank you page of the checkout, along with an emailed link that will last for 30 days.

This template is designed to be customizable. Users should modify the templates as necessary to suit their specific requirements.