Category: Medical
The AI-Enabled Medical Device List is a resource intended to identify AI-enabled medical devices that are authorized for marketing in the United States. Digital health innovators can refer to this list to gain insights into the current device landscape and regulatory expectations, which can help foster innovation and ensure public safety. This list can also provide transparency for health care providers and patients to clearly identify when medical devices use AI technologies.
Contents of the AI-Enabled Medical Devices List:
- The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the device’s overall safety and effectiveness, which includes an evaluation of study appropriateness for the device’s intended use and technological characteristics.
- A direct link to the FDA’s database entry of an AI-enabled medical device is provided. The database entry contains releasable information, such as summaries of safety and effectiveness. Note, the summaries are not all inclusive and do not include most of the information that may be submitted in an application.
- The list is not a comprehensive resource of AI-enabled medical devices. Instead, the list includes AI-enabled medical devices that were identified primarily based on the use of AI-related terms in the summary descriptions of their marketing authorization document and/or the device’s classification. The set of AI terms is based on the FDA Digital Health and Artificial Intelligence Glossary.
- To support transparency in the use of modern AI technologies, the FDA will explore methods to identify and tag medical devices that incorporate foundation models encompassing a wide range of AI systems, from large language models (LLMs) to multimodal architectures. This identification will help innovators, health care providers, and patients recognize when LLM-based functionality is present in a medical device. To facilitate the FDA’s development of methods to identify AI-enabled medical devices more easily, including identifying those devices incorporating LLM-based functionality in a future update of this list, sponsors are encouraged to include appropriate information in their public summaries.
This list will continue to be updated periodically. AI-enabled medical devices that have received authorization but for which decision summaries have not been published within the data collection period will be incorporated into a subsequent update.