FDA's Digital Health Framework
The Digital Health Center of Excellence (DHCoE) is FDA's hub for software and digital health device regulation, established in 2020.
Core framework documents
| Document | Year | Purpose |
|---|---|---|
| Software Functions Guidance | 2023 | Device vs non-device software |
| CDS Software Guidance | 2022 | Regulated vs exempt CDS |
| PCCP Guidance | 2024 | AI/ML change management |
| AI/ML Action Plan | 2021 | Multi-year AI regulatory approach |