MLRagent
Rules/risk disclosure/US-RISK-026

Disclose contraindications from the FDA-required labeling

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

Rule

An SIUU communication should describe any contraindication(s) that appear in the product's FDA-required labeling.

Check

Check the FDA-required labeling for contraindications and confirm each is described in the communication. A violation is an omitted contraindication.

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.

…Devices Fail Product Certification Testing the First Time. Available at <u> https://www.intertek.com/resources/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…
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.