MLRagent
Rules/substantiation/US-SUB-013

Take existing scientific knowledge into account before and during dissemination

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

Rule

Firms should confirm that a source publication remains appropriate in light of current scientific knowledge, checking this both when first preparing the SIUU communication and again at each subsequent dissemination.

Check

Determine whether more recent scientific knowledge has refuted a conclusion from the study described in the source publication or corrected a misunderstanding that informed it. A violation is continuing to share a source publication whose central conclusion has been refuted by later, better evidence.

Escalate when

It is unclear whether newer literature actually refutes (versus merely supplements) the source publication's conclusions.

Where this comes from

Section V, Q1, item 2 · page 16. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…e with a marketed device. For devices, these types of studies, information, and analyses are most likely to be scientifically sound. Additionally, in the case of devices, single-arm studies with comparisons to external controls, non-interventional studies, meta-analyses testing a specific clinical hypothesis, and nonclinical research such as well-designed bench or animal studies may also be scientifically sound. 2. Firms should take into account existing scientific knowledge to determine whether a source publication is appropriate to include in an SIUU communication, both when initially preparing the communication and at the time of each dissemination of that communication. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence </u>. Contains Nonbinding Recommendations Not for Current Implementation—see PRA statement in section VI. A more recent study that generated a different outcome than a previous study does not necessarily make the previous study obsolete or inappropriate to disseminate. However, each time a fi…
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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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FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.