Rules/misleading presentation/US-MIS-056

Material study limitations should be disclosed

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

Rule

FDA recommends that material limitations of a study or analysis relied on in a communication be disclosed.

Check

Confirm that material limitations of any cited study or analysis (e.g., not powered, not pre-specified, descriptive only, small sample, post hoc) are disclosed alongside the claim. A violation looks like a study cited in support of a claim without disclosure of limitations that would affect how a reader should weigh it.

Escalate when

Always — requires judgment about whether an undisclosed limitation is material to the claim.

Where this comes from

Q.6/A.6 · page 15. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…e of their product and from postmarket studies and analyses of their product. As a general matter, FDA believes that a variety of types of studies and analyses can provide useful additional information about a medical product for its approved/cleared conditions of use. However, some of these studies or analyses do not, in and of themselves, allow for reliable conclusions to be drawn about the effects of the product. To be considered truthful and non-misleading, firms’ product communications should not overstate the findings of or the conclusions that can be drawn from such studies or analyses, or fail to disclose their material limitations. For example, certain analyses of pivotal trial data may provide information that elaborates on the data reflected in the product’s FDA-required labeling and could add to understanding of a product (e.g., information from separate analyses of the individual components of a composite endpoint that was successfully used as the primary endpoint and that are derived from appropriate statistical tests and pre-specified i…

Open the original at page 15 on fda.gov ↗Read our full copy →

Document: FDA guidance: Medical Product Communications that Are Consistent With the FDA-Required Labeling – 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: 1a18b7f242bfbbf897f198df…

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

Applies when

Naturepromotional

Basisconsistent-with-labeling

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 the same complete Q.6/A.6 sentence used for US-MIS-022, but this rule takes its second limb ('or fail to disclose their material limitations'), which is a genuinely separate checkable requirement — the split is the correct handling of a two-part sentence rather than duplication.
- Not overstated: stated as an FDA recommendation, matching the source's 'should not... fail to disclose.'
- Atomic: one requirement — disclose material limitations of a relied-upon study or analysis.
- Determinism 'judgment' is correct, since materiality of an undisclosed limitation to the claim being made is an evaluative judgment, as the escalation condition acknowledges.
- Authority 'guidance' matches the source document; applies_when matches the guidance's CFL promotional scope, the Q.6/A.6 locator is right, and 'warning' is defensible.

Nearby rules

US-MIS-022 US-MIS-022 US-MIS-023 US-MIS-024 US-MIS-025 US-SUB-008