Regulatory
Check out our past submission to the FDA
Investigational Device Exemption (IDE)
We have prepared a example version of our original IDE submission for the NNP system, the basis of the COSMIIC System, available for download through the link below.
📁 Click to download a .zip file containing the example IDE, including README & LICENSE
Note: Regulatory requirements and information in this document may have been obsoleted since original submission of these documents. Please refer to the README document for context. For up-to-date technical information on the COSMIIC System, please refer to the pages on this docs site. This document is shared by COSMIIC with the CC-BY-4.0 license.
FDA Communications Regarding Open Source Framework
The COSMIIC team recently held a presubmission with the FDA to discuss opportunities for lessening barriers and creating processes to benefit those submitting future IDEs using open source materials. Below are the request, written feedback, and meeting notes.
| Presubmission request on open source Master File | FDA Response | Meeting Minutes |
|---|---|---|
| 📁 Presubmission file | 📁 FDA Written Feedback | 📁 Meeting minutes from presubmission meeting |