As development of AI accelerates, it creates challenges for government regulation. You’ll hear a brief history of AI/ML regulation and learn the major pathways for software as a medical device to become commercially available. We’ll also cover proposed modifications to the regulatory framework for modifications to AI/ML and ACR® initiatives to support the use of AI in medical imaging.
The Total Product Lifecycle in AI for Radiological Imaging
By: Alex Cadotte, PhD
- Learn about the regulation of radiological AI and ML.
- Understand CDRH’s mission and vision.
- Explore key regulatory concepts.
- Grasp the difference between general and special controls for medical devices.
- Learn the available pre-market submission pathways.
- Get a glimpse of the future of regulation practices.
Overview of FDA Regulatory Framework
By: Howard Chen, MD, MBA
Because updating ML models is unlike updating typical software, it’s not always clear when a new FDA review submission is required. The video gives an overview of the proposed modifications to the regulatory framework for modifications to AI/ML.
- Learn FDA medical device classifications.
- Discover major pathways for “software as medical devices” to become commercially available.
- Understand the needs surrounding an amended process, and the FDA’s proposal.
Regulatory Issues Related to AI: ACR Initiatives
By: Bibb Allen Jr., MD, FACR
- Discover ACR and DSI initiatives to support the use of AI in medical imaging.
- Navigate current challenges in the FDA regulatory process for AI algorithms.
- Learn how to ensure AI is safe and effective for patients.