Evolving Labels and Warnings for AI-Enabled Devices: Managing Risks

When FDA finalized its guidance on Predetermined Change Control Plans (PCCPs) and, shortly after, joined Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in...

FDA Guidance on AI Medical Devices: Predetermined Change Control Plans

One of the challenges regulators face with AI-enabled medical devices is that they are not static products. Unlike a traditional implant or diagnostic tool, the device that receives FDA approval may...