Do not include safety/effectiveness representations inconsistent with the source publication

Where this comes from

Section V, Q5 (prohibited practices) · page 29. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ing presentational considerations in Q3. Additionally, to ensure a firm-generated presentation is truthful and non-misleading, the firm-generated presentation should not, for example, do any of the following: Imply that the study, analysis, or underlying data or information from the source publication represents larger or more-general experience with the medical product than it actually does Include representations or suggestions about the safety or effectiveness of the medical product for the unapproved use(s) that are not consistent with the source publication Present conclusions or representations about safety or effectiveness for the unapproved use, even if they are an accurate reflection of the statements in the source publication, without attributing that statement expressly to the source publication and without immediately following it with the statement identifying any authors, editors, or other contributors to the source publication who were employees of or cons…

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

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