Host SIUU communications on a separate web page from approved-use promotion

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

Rule

When shared online, an SIUU communication should be hosted on a separate web page from any web page that hosts promotional communications about the approved uses of the medical product.

Check

Check whether the SIUU content is hosted on its own web page rather than the page that hosts approved-use promotional content. A violation is SIUU content appearing on the same web page as approved-use promotion.

Where this comes from

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

…s. 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 through the clear and prominent presentation of the disclosures recommended in this guidance. FDA also recommends that firms not include direct links from web pages that host promotional communications about approved uses to web pages that host SIUU communications. Example 3: If a firm chooses to share information about both…

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

Mediumdigital

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 — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The source supports the content: the quote is a whole sentence, verbatim, from Q3 item 2, Example 2, stated in FDA's own recommending voice, and the rule does not strengthen it.
- It is not atomic. The rule bundles two independently checkable requirements: (a) the SIUU content sits on its own web page, separate from any page hosting approved-use promotion, and (b) that page clearly identifies itself through the clear and prominent presentation of the recommended disclosures. A page can satisfy either one while failing the other.
- The determinism flag is wrong for the rule as written. Part (a) is presence/absence, but part (b) turns expressly on prominence — the guidance itself lists type size, font style, layout, contrast, graphic design, headlines and spacing as the factors for 'clearly and prominently presented' — which the rubric classifies as judgment. Labelling the combined rule 'deterministic' understates what a reviewer must do.
- The bundling has already produced an internal inconsistency: the Check's stated violation ('SIUU content on the same web page as approved-use promotion') covers only part (a), so part (b) is asserted in the rule but never resolved into a finding.
- Authority 'guidance' matches the source document, applies_when (hcp, unapproved-use-scientific, digital) is justified by the web-page setting of Example 2, and severity 'warning' is defensible.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the complete first clause of the Example 2 recommendation in Section V, Q3, item 2: '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'. It has its subject and verb, and the trailing 'and that ...' clause is a separate recommendation.
- The rule uses 'should'. It keeps the online condition through 'When shared online' and medium 'digital'. It only has effect where approved-use promotional pages exist, which matches the source's condition that the firm shares both approved and unapproved use information online.
- Whether the SIUU content and the promotion are on the same page is a literal check, so 'deterministic' is correct. The recommendations on page identification and direct links are properly left to other rules. Severity and locator are correct.

Nearby rules

US-SCI-014