The Food and Drug Administration (FDA) is announcing a virtual public workshop on transparency of Artificial Intelligence/Machine Learning (AI/ML)-enabled medical devices to patients, caregivers, and providers. The role of transparency that enhances safe and effective use of AI/ML-enabled medical devices will be discussed, with an emphasis on information sharing methods such as labeling.
The purpose of the workshop is to:
1) identify unique considerations in achieving transparency for users of AI/ML-enabled medical devices and ways in which transparency might enhance the safety and effectiveness of these devices; and
2) gather input from various stakeholders on the types of information that would be helpful for a manufacturer to include in the labeling of and public facing information of AI/ML-enabled medical devices, as well as other potential mechanisms for information sharing.
This workshop builds on the Agency's longstanding commitment to support innovative work in the regulation of digital health technologies, and is a direct response to stakeholder feedback, including feedback from the Agency's Patient Engagement Advisory Committee on AI/ML-enabled medical devices held in October 2020. In January 2021, FDA presented a five-part Action Plan focused on AI/ML-enabled medical devices, which included a proposal to hold a public workshop on how information sharing about a device supports transparency to all users of AI/ML-enabled medical devices. This workshop fulfills that proposal, an important aspect of the Action Plan.