By Brittany Mierzwa – FDA Press Release January 12th 2021 – The FDA has published their Action Plan as they move forward with Artificial Intelligence/Machine Learning (AI/ML) -based software as a Medical Device. The FDA’s vision through AI/ML -based software ‘will deliver safe and effective software functionality that improves the quality of care that patients receive’. AI is being introduced through Radiological Imaging and Cardiac Ultrasound software, both received their first marketing authorizations in February of 2020.
The Action Plan addresses 5 specific concerns that stakeholders have such as apprehensions of cybersecurity, clear transparency as the software trains the algorithm, and regulatory review to ensure the algorithm does not present biases while learning the importance of racially and ethnically diverse patient populations. As the FDA moves forward with their January 2021 Action Plan, AI/ML has become a rapidly progressing field all while maintaining a patient centered approach.