Present required disclosures clearly and prominently

AI-verifiedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

The disclosures recommended in this guidance should be presented clearly and prominently within the SIUU communication.

Check

Assess type size, font, layout, contrast, graphic design, headlines, spacing, and (for audio) volume/articulation/pace used for the disclosures relative to the rest of the piece. A violation is a disclosure that is present but buried, minimized, or hard to notice.

Escalate when

Clarity/prominence is a case-by-case judgment call per FDA's own statement.

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.

…itation). Q3. What presentational considerations should firms take into account for SIUU communications? There are several presentational considerations that can help ensure that SIUU communications are conveyed in a manner that enhances and does not interfere with HCP understanding and evaluation of the underlying scientific information, including its limitations. To that end, FDA recommends the following: 1. SIUU communications should clearly and prominently present the disclosures recommended in this guidance. Recommended disclosures should be clearly and prominently presented. 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, p…

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 — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence and is the first numbered recommendation under Q3: 'SIUU communications should clearly and prominently present the disclosures recommended in this guidance.' The rule statement is a direct, unembellished restatement.
- No overstatement: the recommendatory 'should' is preserved and nothing is added about what counts as a violation beyond FDA's own prominence factors.
- Determinism 'judgment' is correct — prominence turns on impression, and the check's factors (type size, font style, layout, contrast, graphic design, headlines, spacing, volume, articulation, pace) are taken verbatim from FDA's own list in the following paragraph.
- Single requirement; severity 'warning' is defensible; authority 'guidance' matches; locator (Section V, Q3, item 1) and the HCP / unapproved-use-scientific scoping are correct.

Nearby rules

US-DISC-011