Presubmissions
Sharing responses by the FDA to our open source questions
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 written response to open source master file | Presubmission Meeting Minutes. Discussion on FDA response |
|---|---|---|