Rules/misleading presentation/US-MIS-036

Do not imply the source data represents broader experience than it does

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

Rule

A firm-generated presentation should not imply that the study, analysis, or underlying data from a source publication reflects larger or more general experience with the medical product than it actually does.

Check

Compare claims/tone in the presentation against the actual scope (sample size, population, setting) of the underlying study or data. A violation is language or framing suggesting broader real-world experience than the source data supports.

Escalate when

Whether wording overstates the generality of the underlying experience is a matter of interpretation.

Where this comes from

Section V, Q5 (prohibited practices) · page 29. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ion could include the following statement: "This presentation was developed by FIRM X." Firm-generated presentations should be consistent with the recommendations in this guidance regarding presentational considerations in Q3. Additionally, to ensure a firm-generated presentation is truthful and non-misleading, the firm-generated presentation should not, for example, do any of the following: Imply that the study, analysis, or underlying data or information from the source publication represents larger or more-general experience with the medical product than it actually does Include representations or suggestions about the safety or effectiveness of the medical product for the unapproved use(s) that are not consistent with the source publication Present conclusions or representations about safety or effectiveness for the unapproved use, even if they are an accurate reflection of the statements in the source publication, without attributing that statement expressly to the source pu…

Open the original at page 29 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 enumerated item from the Q5 list introduced by 'to ensure a firm-generated presentation is truthful and non-misleading, the firm-generated presentation should not, for example, do any of the following'. The item is a whole clause as the source prints it; the rule restores the elided subject ('a firm-generated presentation') correctly rather than inventing one.
- Not overstated: the rule is scoped to firm-generated presentations, matching the source, and keeps 'should not'.
- Atomic: one failure mode — implying broader or more general experience than the underlying data supports.
- Determinism 'judgment' is right: this turns on the impression created by wording and framing.
- Authority 'guidance' matches the source document; no statutory restatement.
- applies_when is justified (HCP audience, scientific information on unapproved use); the firm-generated-presentation limit is carried in the rule text, which the scoping vocabulary cannot express.
- Severity 'warning' is lower than the sibling Q5 items but is defensible: the failure mode is one of framing/implication rather than an affirmative safety or effectiveness claim contradicting the source.
- Violable and checkable against the source publication's sample size, population and setting.

Nearby rules

US-MIS-037 US-MIS-038 US-MIS-039 US-MIS-040