CDRH Outlines Vision for Good Machine Learning Practices

The FDA’s vision for good machine learning practices, outlined in a discussion paper, could ease reviews of such technology, said Matthew Diamond, the agency’s medical officer for digital health. He noted “synergy” between the discussion paper and the FDA’s Software Precertification Program, saying “the two approaches share a common goal, which is to align the regulatory process with the natural lifecycle of software and to facilitate movement of these technologies in a safe manner to the public as timely as possible.”