Match audio and text disclosures for audio-visual SIUU communications

AI-verifiedwarningFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

For an SIUU communication with both audio and visual components, the disclosures recommended in this guidance should appear simultaneously in the audio and in on-screen text, using the same words (either key terms/phrases or a full transcript).

Check

Compare the audio disclosure language to the simultaneous on-screen text. A violation is a disclosure spoken but not shown in text at the same time (or vice versa), or text that uses different words than the audio.

Where this comes from

Section V, Q3, item 1 · page 20. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…resented. This helps to ensure that HCPs have the information necessary to interpret the scientific information and the SIUU communication as a whole. Factors FDA considers when determining whether information is clearly and prominently presented may include type size, font style, layout, contrast, graphic design, headlines, spacing, volume, articulation, pace, and any other techniques to achieve emphasis or notice. For SIUU communications that have both audio and visual components, to help HCPs notice and comprehend the information, FDA recommends that disclosures be presented in both the audio and in text at the same time using the same words (key terms and phrases or a full transcript). Note, for SIUU communications that have both audio and visual components, it would be consistent with the disclosure recommendations of this guidance for both the audio and visual components to include a statement about how to obtain a copy of the most current FDA-required labeling for the medical product that is the subject of the SIUU communication. Contains Nonbinding Recommendations Not fo…

Open the original at page 20 on fda.gov ↗Read our full copy →

Document: FDA guidance: Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers (final)
Version: as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved: 2026-09-21 from www.fda.gov
Fingerprint: a36a07e1efd950b7a2a8f6b3…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Audiencehcp

Basisunapproved-use-scientific

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence from the Q3 item 1 discussion and supports the rule: for SIUU communications with both audio and visual components, FDA recommends disclosures be presented in both the audio and in text at the same time using the same words.
- The scoping is wrong in a way that under-applies the rule: the source condition is 'SIUU communications that have both audio and visual components', not broadcast media. Restricting applies_when.medium to 'broadcast' would exempt web video, webinars, and other non-broadcast audio-visual pieces that the source squarely covers. The audio+visual condition is already stated in the rule text, so the medium filter is not needed to carry it.
- The rule calls them 'the required disclosures' where the guidance calls them recommended disclosures; in a non-binding guidance this wording reads as an obligation.
- Determinism 'deterministic' is defensible: the check is whether the same words appear in audio and on-screen text at the same time, which is settled by comparison rather than impression. Severity 'warning', authority 'guidance', and the Q3 item 1 locator are correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a whole sentence from Section V Q3, item 1: 'FDA recommends that disclosures be presented in both the audio and in text at the same time using the same words (key terms and phrases or a full transcript).' The rule restates it with 'should'.
- The rule text states the limit to communications with both audio and visual components, which the fixed scoping vocabulary cannot express. That is acceptable.
- Whether the audio and the text say the same words at the same time is a literal comparison, so 'deterministic' is acceptable. Severity and the locator 'Section V, Q3, item 1' are correct.

Nearby rules

US-DISC-010