Mayo Clinic April 19, 2023
The agency recently posted new recommendations for AI developers who want to update their software as a medical device (SAMD). The document offers what we hope will be a less burdensome way to manage the Predetermined Change Control Plan.
By John Halamka, M.D., President, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform.
Bob Dylan said it best, the times really are changing. Although he didn’t have the Food and Drug Administration (FDA) in mind when he wrote his protest song, the agency realizes it needs to revise its AI-related software guidelines and regulations to keep pace with an ever-evolving AI landscape. Unfortunately, the acronyms that describe the new regulations can get confusing, including...
Today's Sponsors
Today's Sponsor