4th International Conference on
AI in Healthcare, Industry & Regulatory Affairs
May 25–27, 2027 | Toronto, Canada
Four Points by Sheraton Toronto Hotel
Address: Mississauga, 6090 Dixie Road, Mississauga, ON, L5T 1A6, Canada
AIHIRA 2027
FDA AI/ML Guidance
This topic focuses on the U.S. FDA's regulatory approach to AI/ML-enabled medical devices.
A major area of interest is how AI/ML software can be developed, validated, modified, and monitored while maintaining safety and effectiveness.
Important areas include:
- AI/ML-enabled medical devices
- Software as a Medical Device (SaMD)
- FDA premarket pathways
- 510(k)
- De Novo
- PMA
- Clinical evaluation
- Software validation
- Good Machine Learning Practice (GMLP)
- Transparency
- Human-AI interaction
- Cybersecurity
- Post-market monitoring
- AI/ML model modifications
A particularly attractive conference topic is Predetermined Change Control Plans (PCCP)—how manufacturers can establish a controlled framework for certain planned AI/ML changes without treating every anticipated modification as an entirely new product.