Keep SIUU communications separate from promotional communications about approved uses

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

Rule

An SIUU communication should be kept separate from any promotional communication about the product's approved uses, so HCPs do not conflate approved and unapproved use information.

Check

Check whether the SIUU communication is attached to, intermingled with, or presented alongside promotional material for approved uses. A violation is combining or co-locating the two without clear separation.

Escalate when

Whether a particular layout or proximity amounts to impermissible 'combining' requires judgment.

Where this comes from

Section V, Q3, item 2 · page 21. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…components, it would be consistent with the disclosure recommendations of this guidance for both the audio and visual components to include a statement about how to obtain a copy of the most current FDA-required labeling for the medical product that is the subject of the SIUU communication. Contains Nonbinding Recommendations Not for Current Implementation—see PRA statement in section VI. 2. SIUU communications should be separate from promotional communications about approved uses of medical products. As set forth in this guidance, the medical products that are discussed in SIUU communications are approved/cleared for at least one use, and, as such, it is likely that firms disseminate promotional communications for those approved uses. However, combining approved use and unapproved use information has the potential to undermine the government interests in the premarket requirements of the FDA Authorities (see se…

Open the original at page 21 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 the verbatim heading sentence of Q3 item 2 ('SIUU communications should be separate from promotional communications about approved uses of medical products.') — a whole sentence stating a recommendation in the guidance's own voice, not an example.
- Not overstated: the rule keeps 'should be kept separate'. The rationale appended to the rule ('so HCPs do not conflate approved and unapproved use information') is drawn directly from the same passage, which explains that combining the two 'can prompt conflation of the information'.
- Atomic: one requirement — separation. The companion recommendation that SIUU communications be clearly identified through clear and prominent disclosures is correctly left out of this rule.
- Determinism 'judgment' is right: the source's gloss is 'not attached to or intermingled with', so proximity and layout must be weighed rather than literally matched.
- Authority 'guidance' matches the source document; nothing statutory is restated.
- applies_when (hcp, unapproved-use-scientific) matches the guidance's scope, and no medium limit is appropriate since the source states this generally before giving medium-specific examples.
- Severity 'warning' is defensible for a presentational recommendation under a non-binding guidance.