AI, ML, & Cybersecurity: Here's What FDA May Soon Be Asking

FDA has released a number of documents that could help clarify its expectations for artificial intelligence, machine learning, and cybersecurity. These include Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan, published in January 2021; Good Machine Learning Practice for Medical Device Development: Guiding Principles, published in October 2021; and the just-released draft guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The AI/ML action plan provides a "more tailored regulatory framework for AI/ML," explained Pavlovic. She referred to FDA's 2019 discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) - Discussion Paper and Request for Feedback, which laid out a "total product lifecycle approach to AI/ML regulations with the understanding that AI/ML products can be iterated much more efficiently and quickly than a typical medical device implant product or something that isn't software based." This is "because there is an opportunity to add additional data to training sets on which the products were originally formulated," she said.