Disclose labeling limitations, restrictions, cautions, warnings, or precautions about the unapproved use

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

Rule

An SIUU communication should disclose any limitations, restrictions, cautions, warnings, or precautions in the FDA-required labeling that bear on the unapproved use being discussed.

Check

Check whether the FDA-required labeling contains any limitation, restriction, caution, warning, or precaution relevant to the unapproved use, and whether the communication discloses it. A violation is an applicable labeling caution that goes undisclosed.

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.

… 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, cautions, warnings, or precautions described in the FDA-required labeling about the unapproved use(s) Similarly, medical devices have a very high failure rate in their first prototype tests, with a reported 90 percent of medical devices failing in their first prototype tests (see Intertek (2010). The Top 10 Reasons Medical Devices Fail Product Certification Testing the First Time. Available at <u> https://www.intertek.com/resources/white-papers/2021/electrical-top-ten-reasons-products-fail/ </u>). <!-- page 19 -…

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
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 bulleted item under Q2 verbatim, governed by the stem 'FDA recommends that firms include all of the following information as part of SIUU communications'. The rule restates it as a 'should disclose' recommendation, matching the modality.
- Not overstated: the rule keeps the source's limit to items 'described in the FDA-required labeling about the unapproved use(s)' by requiring only labeling content that bears on the unapproved use under discussion. It does not demand disclosure of all labeling cautions.
- Atomic: one disclosure requirement. The five nouns (limitations, restrictions, cautions, warnings, precautions) enumerate the covered labeling content, not separate checks.
- Determinism 'deterministic' is right: the comparison is against a fixed document (the FDA-required labeling) and the finding is whether identified labeling content appears in the communication. Nothing turns on impression, adequacy, prominence or balance.
- Authority 'guidance' matches the source document; this is FDA's recommendation, not a regulation the guidance quotes.
- applies_when matches the Q2 scope of SIUU communications to HCPs.
- Severity 'warning' is defensible and consistent with the sibling Q2 disclosure rules.

Nearby rules

US-DISC-005 US-DISC-006 US-DISC-007 US-DISC-008 US-DISC-009 US-IND-014 US-RISK-024 US-RISK-026 US-RISK-027 US-RISK-028 US-SUB-016