MLRagent
Rules/risk disclosure/US-RISK-024

Disclose that the unapproved use is unapproved and unestablished

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

Rule

An SIUU communication should include a statement that the discussed unapproved use has not been approved by FDA and that the safety and effectiveness of the product for that use has not been established.

Check

Look for an explicit statement disclosing both (a) that FDA has not approved the use and (b) that safety and effectiveness for that use are unestablished. A violation is the absence of either element.

Where this comes from

Section V, Q2 · page 18. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…UU communication. 3. Any conclusions articulated in a source publication should align with the prespecified hypothesis or research question from the described study or analysis and be supported by the results from that study or analysis. Q2. What information should firms include as part of SIUU communications? FDA recommends that firms include all of the following information as part of SIUU communications: A statement that the unapproved use(s) of the medical product has not been approved by FDA and that the safety and effectiveness of the medical product for the unapproved use(s) has not been established For example, a statement that "[Medical Product X] has not been approved by FDA for use in [Condition Y], and the safety and effectiveness of [Medical Product X] for [Condition Y] has not been established." A statement disclosing the FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling A statement disclosing any limitations, restrictions, cauti…
Open the original at page 18 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
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FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.