FDA and Regulation
FDA pathways, SaMD, adaptive AI oversight, regulatory terminology, and postmarket monitoring for clinical AI.
About FDA and Regulation
FDA and regulatory coverage for clinical AI must be precise. A tool may be cleared, approved, authorized, registered, or marketed under another pathway, and those labels are not interchangeable. This section is designed to help clinicians, buyers, and vendors understand those differences without relying on vague shorthand.
Regulatory status also changes over time. Coverage here focuses on the intended use of the software, the pathway used, what that status does and does not mean, and how ongoing monitoring affects adoption decisions.
What This Section Covers
- How the FDA regulates clinical AI
- Software as a Medical Device
- Clearance, approval, authorization, and other regulatory terms
- Adaptive AI oversight and change control planning
- Postmarket monitoring and lifecycle oversight
- International regulatory comparisons where relevant
Initial Article Queue
- How the FDA Regulates Clinical AI
- What Is Software as a Medical Device?
- FDA-Cleared vs FDA-Approved AI Medical Software
- FDA-Cleared Clinical AI Tools
- FDA Regulation of Adaptive AI
- Predetermined Change Control Plans for Medical AI
- Clinical AI Regulatory Pathways
- Postmarket Monitoring of Medical AI
- International Regulation of Clinical AI
- Clinical AI Regulatory Updates
Editorial Standard for This Section
Regulatory content should always identify source date, last reviewed date, primary sources, and the exact regulatory term being used. Regulatory status may change, so every article in this section should be revisited on a regular review cycle.