MLRagent
Rules/scientific exchange/US-SCI-022

Excerpted clinical reference resource sections must include all information needed to interpret them

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

Rule

When a firm shares only individual section(s) of a CPG, reference text, or digital clinical practice resource, the SIUU communication should include all information from that resource necessary for HCPs to interpret the strengths, weaknesses, validity, and clinical utility of the scientific information presented.

Check

Check whether the excerpted section(s) omit related or linked information (e.g., methodology, evidence ratings, caveats) needed to interpret the presented information. A violation is an excerpt that strips out context necessary for interpretation.

Escalate when

Whether omitted surrounding material is 'necessary' for interpretation is a judgment call.

Where this comes from

Section V, Q4, item 2 (Clinical Reference Resources) · page 24. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…digital clinical practice resources These clinical reference resources often contain information about unapproved uses of approved/cleared medical products. Therefore, when sharing SIUU communications that include CPGs, reference texts, or materials from digital clinical practice resources, FDA recommends that firms follow the recommendations in Q1, Q2, and Q3, subject to the following additions and modifications. When a firm shares an SIUU communication that includes one or more individual section(s) of any of these clinical reference resources, the SIUU communication should include all information from the clinical reference resource necessary for HCPs to interpret the strengths and weaknesses, validity, and clinical utility of the scientific information on unapproved use(s) that the clinical reference resource presents. This may involve the sharing of multiple sections of the clinical reference resource that contain related or linked information. When a firm shares individual section(s) from these clinical reference resources, those individual section(s) should be unaltered/unabridged and extracted directly from the clinical reference resource. Because unabridged CPGs and reference texts in their entirety generally discuss a wide …
Open the original at page 24 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)
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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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a36a07e1efd950b7a2a8f6b3…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.