Check FDA’s AI-Enabled Device List for Marketing Authorization

FDA recently updated an online directory called the AI-Enabled Medical Devices list. The list is designed to help you check whether an AI-enabled medical device has FDA marketing authorization in the United States—and to link you to the FDA page that summarizes the device’s authorization information.

This is useful in everyday care because “AI-enabled” tools may be used for things like detection, measurement, triage, or clinical decision support. But authorization is only one part of safety and effectiveness. The best next step is to check the linked FDA database entry for the specific device and discuss practical details with your care team.

What changed: FDA shows an update on June 16, 2026

FDA’s Center for Devices and Radiological Health (CDRH) “New news and updates” feed indicates that the Artificial Intelligence-Enabled Medical Devices list was marked Updated on June 16, 2026.

What the AI-Enabled Medical Devices list is for

FDA describes the list as a transparency tool to help people find AI-enabled medical devices that have FDA marketing authorization and to link those devices to FDA’s authorization information.

When you open the list, you’ll typically see:

Devices listed in reverse chronological order (based on FDA’s “Date of Final Decision”).
A direct link from each device in the table to the FDA database entry for that decision.
Releasable information in the linked FDA database entry, including summaries of safety and effectiveness (where available).

How to check a specific device’s authorization (step by step)

Collect what you were told about the device.

Ask the clinic, hospital, imaging center, or specialty practice for the device name and the company. If your paperwork includes identifiers (like a submission/decision number), keep those too—searching can be easier.
Find it on the FDA AI-Enabled Medical Devices list.

Use the list’s table to look up the device name or company.
Open the linked FDA database entry.

FDA provides a direct link so you can review the releasable information tied to that device’s authorization decision.
Read for intended use—and the limits of what’s shown publicly.

FDA emphasizes that public summaries are not all-inclusive and may not include most of the information contained in the underlying application materials.
Use the “Date of Final Decision” as context.

A more recent decision doesn’t automatically mean “safer for everyone,” and an older decision doesn’t automatically mean “outdated.” It mainly helps you understand the timeframe of FDA’s authorization decision.

Key limits: what the list can’t tell you

It’s not a complete inventory.

FDA states the list is not comprehensive and is based largely on identifying AI-related terms in device authorization materials and classification.
Linked summaries aren’t the full record.

FDA also notes that the publicly available summaries in the linked database entry are not all-inclusive and may not include most of the information submitted to FDA.
Public clinical evidence may appear incomplete for some devices.

A JAMA Network Open study described how missing publicly available information about supporting clinical studies was associated with a higher hazard of recall in its retrospective modeling. The authors also discuss limitations of their approach. This kind of finding is an association, not proof that any specific device’s authorization is unsafe.

Practical takeaway: Use the FDA list and linked entries to ask better questions and understand intended use and authorization context—not to replace clinical judgment or decide whether a tool is appropriate for your individual situation.

How AI should fit into care: human oversight still matters

Even when a device is FDA-authorized, AI-enabled tools are not a substitute for clinical judgment. CDC’s guidance for generative AI in public health emphasizes that human oversight is essential because outputs can be inaccurate, and it calls for careful review for quality and errors. The American Medical Association similarly states that AI should support—not replace physician judgment, with attention to transparency and meaningful clinical oversight.

What to ask your clinician or clinic team

What AI-enabled tool are you using, and what exact task does it support? (For example: detection, measurement, triage, or clinical decision support.)
How is the AI output used? Is it reviewed alongside other clinical information, or does it feed directly into decisions?
Is there a manual review step? Who reviews the output, and what happens when the output conflicts with other information?
Where can I find the FDA authorization information for this device?
What uncertainties or common failure modes are you watching for in this specific clinical workflow?

When symptoms are urgent

If you or a loved one has severe, rapidly worsening, or emergency symptoms, seek urgent or emergency care right away. The FDA device list is about authorization status—not whether your specific symptoms require immediate evaluation.

Sources

Editorial note: Weence articles are researched from cited public-health, medical, regulatory, journal, and reputable news sources and may be drafted with AI assistance. They are checked for source support, clarity, and safety guardrails before publication.

This article is for general informational purposes only and is not medical advice. Research findings can be early or incomplete, and health guidance can change. Always talk with a qualified healthcare professional about personal symptoms, diagnosis, medications, vaccines, screenings, or treatment decisions. If you think you may have a medical emergency, call emergency services right away.