torchbearercommunity.substack.com/p/what-happens-when-we-automate-our
1 correction found
FDA-approved AI tools
This uses the wrong FDA term. Most radiology AI devices are FDA-cleared or otherwise authorized for marketing, not FDA-approved via the stricter PMA approval pathway.
Full reasoning
This phrase is technically inaccurate in a way that matters.
The FDA's own AI-Enabled Medical Device List says it identifies devices that are "authorized for marketing in the United States". That list includes many radiology devices, but the FDA does not describe the whole list as "approved" devices.
The distinction matters because the FDA separates:
- 510(k) clearance: a device is found substantially equivalent to an existing marketed device.
- PMA approval: the FDA's stricter approval pathway for certain higher-risk devices.
On the FDA AI-device list, the radiology entries are overwhelmingly labeled with K-numbers (for example, K254207, K252360, K253649), which are 510(k) clearances, not PMA approvals. So saying radiologists are working alongside "hundreds of FDA-approved AI tools" overstates the regulatory status of most of these systems. A more accurate phrasing would be "FDA-cleared" or "FDA-authorized" AI tools.
2 sources
- Artificial Intelligence-Enabled Medical Devices | FDA
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... Use the Submission Number link to display the approval, authorization, or clearance information for the device.
- Device Approvals and Clearances | FDA
A 510(k) is a premarketing submission... substantially equivalent... not subject to premarket approval (PMA)... Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA.