Shared reference text/digital resource should be authored by demonstrated subject-matter experts

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

Rule

A reference text or digital clinical practice resource included in an SIUU communication should be authored, edited, and contributed to by individuals with demonstrated subject-matter expertise (via education or experience).

Check

Check contributor credentials against the subject matter covered. A violation is content authored/edited/contributed to by individuals lacking demonstrated relevant expertise.

Escalate when

Whether the authors, editors and contributors have demonstrated expertise in the relevant subject area through education or experience requires judgment, and contributor credentials may not be disclosed.

Where this comes from

Section V, Q4, item 2.b (Reference Texts / Digital Clinical Practice Resources) · page 27. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

This rule is one item of a list. The list is introduced by: FDA recommends that a reference text or material from a digital clinical practice resource have all of the following characteristics if a firm chooses to include it in an SIUU communication:

…ooses to include it in an SIUU communication: It is published by an independent publisher that is in the business of publishing scientific or medical educational content It is published in a manner consistent with current standards for medical content creation and review that are generally accepted by the medical publishing industry and in accordance with any specific peer-review procedures of the publisher It is authored, edited, and contributed to by experts who have demonstrated expertise in the subject area(s) through education or experience It is generally available or sold through independent distribution channels (e.g., internet sources, book retailers, subscriptions, libraries) for medical and scientific educational content Reference texts or material(s) from digital clinical practice resources that misrepresent or overstate findings from a study or analysis in light of the limitations of such study or analysis would not fall within the enforcem…

Open the original at page 27 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 — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported: the bullet sits in Q4 item 2.b under 'FDA recommends that a reference text or material from a digital clinical practice resource have all of the following characteristics if a firm chooses to include it in an SIUU communication'.
- Not overstated: 'should be authored, edited, and contributed to by individuals with demonstrated subject-matter expertise' tracks the source clause, and the recommendatory modality is preserved.
- Atomic: one contributor-qualification characteristic covering authors, editors and contributors as the source states them together; one finding.
- 'deterministic' is wrong. 'Demonstrated expertise in the subject area(s) through education or experience' is an adequacy assessment of credentials against the subject matter - exactly what the rule's own check asks for - not something settled by presence/absence or a literal match. US-SCI-019 in this same corpus treats the equivalent 'demonstrated expertise' assessment as judgment and escalates on it.
- applies_when, the Q4 item 2.b locator and 'warning' severity are all defensible.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Q4 item 2.b lists authorship/editing by demonstrated experts as a characteristic FDA 'recommends' for reference texts and digital clinical practice resource materials; the rule text says 'should', but the title says 'must be authored', overstating it.
- The quote 'It is authored, edited, and contributed to by experts ...' is a bare list item whose subject 'It' is undefined without the lead-in 'FDA recommends that a reference text or material from a digital clinical practice resource have all of the following characteristics if a firm chooses to include it in an SIUU communication:'.
- Judgment is correct; the rule is atomic.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim the third characteristic in Q4 item 2.b, and the rule and title use 'should'.
- Judgment is correct because expertise requires assessment.
- The quote begins 'It is authored...', and 'It' refers to something outside the quote. The introducing sentence is not adjacent (the 'published in a manner consistent with current standards' characteristic comes between), and there is no lead_in. The quote therefore drops both its subject and its recommendation framing.
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote 'It is authored, edited, and contributed to by experts who have demonstrated expertise in the subject area(s) through education or experience' is a verbatim, complete list item from Section V, Q4, item 2.b.
- The lead_in 'FDA recommends that a reference text or material from a digital clinical practice resource have all of the following characteristics if a firm chooses to include it in an SIUU communication:' is verbatim. Read together, they establish the recommendation, including the condition that it applies when a firm includes such material.
- The title and rule use 'should', consistent with the guidance's authority. The rule preserves authored/edited/contributed and 'through education or experience'.
- The rule is a single characteristic from the list, so it is atomic. Judgment is correct because expertise must be assessed.
- The applies_when scope, the warning severity and the locator are all appropriate.
- Minor, not required: the check's word 'violation' is strong for a guidance recommendation.

Nearby rules

US-MIS-034 US-SCI-028 US-SCI-029 US-SCI-031