Shared CPG must be one that is revised as new evidence warrants

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

Rule

A CPG included in an SIUU communication should be one that its issuing organization revises when important new evidence warrants modifying current recommendations.

Check

Check the CPG's revision history/policy for evidence of periodic updates when warranted. A violation is sharing a CPG known to be outdated relative to important new evidence with no update process.

Escalate when

Determining whether 'important new evidence' has emerged that should have triggered revision requires clinical judgment.

Where this comes from

Section V, Q4, item 2.a (CPGs) · page 25. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…lowing characteristics if a firm chooses to include it in an SIUU communication: The CPG is based on rigorous reviews of the existing evidence conducted according to a clear, established procedure and following a transparent process that minimizes biases and conflicts of interest The CPG includes ratings of the recommendations to reflect the quality and strength of evidence that supports each recommendation The CPG is revised when important new evidence warrants modifications of current recommendations The CPG is generally available through independent distribution channels (e.g., internet sources, book retailers, subscriptions, libraries) where CPGs are sold or are accessible CPGs 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 enforcement policy outlined in this guidance. One helpful resource w…

Open the original at page 25 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 complete bullet from Q4 item 2.a, and the source reinforces it later ('any CPG recommendations are updated when new evidence warrants modification'), so the rule statement follows from the source.
- Not overstated: the rule attributes the revision practice to the issuing organization, which is the natural reading of a characteristic FDA recommends the CPG have, and keeps 'should'.
- Atomic: one characteristic, one finding.
- 'judgment' is correct - deciding whether important new evidence has emerged that should have triggered revision is a clinical assessment, as the escalate note states.
- Violable and checkable via the CPG's revision history/policy. Severity 'note' is lower than the sibling CPG rules but defensible: this characteristic is about the CPG series' maintenance practice rather than a defect visible in the shared piece. Locator and applies_when are correct.

Nearby rules

US-MIS-033 US-SCI-024 US-SCI-025 US-SCI-027