Disclose serious, life-threatening, or fatal risks relevant to the unapproved use

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

Rule

An SIUU communication should describe any serious, life-threatening, or fatal risks of the product that are in the FDA-required labeling or otherwise known to the firm and relevant to the unapproved use.

Check

Identify serious/life-threatening/fatal risks in labeling or known to the firm that bear on the unapproved use, and confirm each is disclosed. A violation is an undisclosed relevant serious risk.

Escalate when

Whether a known (non-labeled) risk is 'relevant to the unapproved use' requires clinical judgment.

Where this comes from

Section V, Q2 · page 19. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…esources/white-papers/2021/electrical-top-ten-reasons-products-fail/ </u>). Contains Nonbinding Recommendations Not for Current Implementation—see PRA statement in section VI. A copy of the most current FDA-required labeling (or a mechanism for obtaining this labeling, as appropriate) A statement describing any contraindication(s) in the FDA-required labeling for the medical product A statement describing any serious, life-threatening, or fatal risks posed by the medical product that are in the FDA-required labeling for the medical product or known by the firm and that are relevant to the unapproved use(s) If a risk evaluation and mitigation strategy (REMS) has been established under 21 U.S.C. 355-1, the statement should disclose that fact and should describe the goal(s) of the REMS A statement identifying any authors, editors, or other contributors to publication(s) included in the SIUU communication who were employees of or consultants to or who received compensation from the firm at the time of writing, edit…

Open the original at page 19 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 a complete bulleted item under Q2 verbatim, and the rule restates it with the 'should' modality supplied by the 'FDA recommends that firms include all of the following' stem.
- Not overstated: the rule preserves both source limits — the risks must be serious, life-threatening or fatal, and must be in the FDA-required labeling or known by the firm and relevant to the unapproved use. It does not extend to all known risks.
- Atomic: one disclosure requirement with a single defined class of risks; 'in the labeling or known by the firm' describes the sources of the risks to be disclosed, not two separate obligations.
- Determinism 'judgment' is right and is the correct call given the sibling disclosure rules: identifying non-labeled risks 'known by the firm' and judging relevance to the unapproved use requires clinical evaluation rather than a literal match. The escalation note states this precisely.
- Authority 'guidance' matches the source document.
- applies_when matches the Q2 SIUU-to-HCP scope.
- Severity 'warning' is defensible and consistent with the other Q2 disclosure rules.

Nearby rules

US-DISC-005 US-DISC-006 US-DISC-007 US-DISC-008 US-DISC-009 US-IND-014 US-RISK-024 US-RISK-025 US-RISK-026 US-RISK-028 US-SUB-016