1. The Medical Device Development Tools program
The FDA proposed this program—a pathway for the agency to qualify tools that medical device sponsors could use in the development and evaluation of their devices—last August. For a device to pass qualification, it must be determined by the FDA that it “produces scientifically plausible measurements and works as intended within the specified context of use.”
According to Allen, the tools can be developed by private groups or sponsors themselves, but will be helpful in the approval process for AI algorithms and other less-than-tangible softwares.
2. The National Evaluation System for Health Technology, or NEST
NEST exists to move medical devices from their nascent stages to market as quickly as possible, while “strategically and systematically leveraging real-world evidence and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices.”
The FDA claims it’ll make that happen by shifting to more active surveillance, therefore improving its ability to detect safety issues. NEST is also designed to leverage real-world data with the goal of generating better, more widely applicable evidence representative of a diverse U.S. population.
3. The ACR Data Science Institute and Lung-RADS Assist
Allen said the NEST Coordinating Center chose the Lung-RADS Assist: Advanced Radiology Guidance, Reporting and Monitoring program as a way to demonstrate its newfound approach to the evaluation of AI algorithms. The project, sponsored by the ACR Data Science Institute, is a method for validating and monitoring AI algorithms built to detect and classify lung nodules in lung cancer screening programs as defined by Lung-RADS.
“The demonstration will use real-world data to assess end-to-end workflow from the deployment of an AI algorithm in a radiology reporting system through the capture of performance metrics within a national registry,” Allen wrote.
“This example of a public-private partnership may serve as a model for how AI algorithms can be monitored in clinical practice to ensure ongoing patient safety while establishing a pathway to increase the efficiency of the FDA premarket review process.”