MLRagent
Rules/scientific exchange/US-SCI-025

Shared CPG must rate the strength/quality of evidence for its recommendations

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

Rule

A CPG included in an SIUU communication should include ratings reflecting the quality and strength of evidence supporting each of its recommendations.

Check

Check whether the CPG assigns an evidence-quality/strength rating to each recommendation. A violation is a CPG lacking such ratings.

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.

…ondition, in addition to offering potential alternatives for certain patient subgroups. FDA recommends that a CPG have all of the following 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 fal…
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.