Use a dedicated, separate exhibit-hall space for SIUU communications

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

Rule

In commercial exhibit halls, firms should divide booth space so SIUU communications are shared in a space dedicated to that purpose, separate from the space used for promotional communications about approved uses.

Check

Observe whether SIUU material at a booth occupies a distinctly separate area from promotional material about approved uses. A violation is SIUU and promotional material sharing the same undivided booth space.

Where this comes from

Section V, Q3, item 2, Example 1 · page 22. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ues where programming is not selected and determined by the conference organizers, firms should ensure that SIUU communications are clearly identified through the clear and prominent presentation of the disclosures recommended in this guidance and are separate from (i.e., not attached to or intermingled with) promotional communications about approved uses. For example, in commercial exhibit halls, FDA strongly recommends that firms divide booth space to allow for a dedicated space where SIUU communications can be shared, separate from the booth space where promotional communications about approved uses are shared. Example 2: If a firm chooses to share information about both the approved and unapproved uses of its medical products to HCPs online through websites, FDA recommends that SIUU communications be on a separate web page from the web page that hosts promotional communications about the approved uses of the medical product and that the web page for the SIUU communications clearly identifies those communications throug…

Open the original at page 22 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

Mediumin-person

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 whole sentence, verbatim. Although it sits inside Example 1, it is itself an FDA recommendation in the agency's own voice ('FDA strongly recommends that firms divide booth space...'), not an illustration of some other rule being applied — and the rule is scoped to the very scenario the example describes (commercial exhibit halls), so nothing is generalized beyond the source.
- Not overstated: 'strongly recommends' is rendered as 'should', which is if anything weaker; no obligation is asserted.
- Atomic: one requirement — a dedicated booth space for SIUU communications, separate from the approved-use promotional space.
- Determinism 'judgment' is right: whether a booth area is meaningfully 'dedicated' and 'separate' turns on the impression the physical layout creates.
- Authority 'guidance' matches the source document.
- applies_when is well chosen: medium 'in-person' captures the exhibit-hall setting, and the hcp/unapproved-use-scientific pair matches the guidance's scope.
- Severity 'note' is low relative to the sibling separation rules, but it is defensible: this is a venue-specific elaboration of the general separation recommendation (US-SCI-011) rather than an independent substantive requirement.