FDA
Guidances
Especially in the space of digital health, wearables, and med devices the FDA puts out important guidances pretty regularly. This is a good place to browse but I also list some guidances I have found particularly relevant or interesting below.
When updates are made often the docs at the URL change, so something I have listed as “2020” may have been refreshed.
2021
- Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions
- Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan
2020
- Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)
- Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol