Provide a copy of or mechanism to obtain current FDA-required labeling

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

Rule

FDA recommends that an SIUU communication include, among the other recommended items, a copy of the most current FDA-required labeling, or a mechanism for the HCP to obtain it.

Check

Look for an attached current label or a clear means (e.g., a link) to obtain it. A violation is providing outdated labeling or no way to access it.

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.

This rule is one item of a list. The list is introduced by: FDA recommends that firms include all of the following information as part of SIUU communications:

…rcent of medical devices failing in their first prototype tests (see Intertek (2010). The Top 10 Reasons Medical 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…

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

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The substance is supported: the Q2 list includes 'A copy of the most current FDA-required labeling (or a mechanism for obtaining this labeling, as appropriate)', under the stem 'FDA recommends that firms include all of the following information as part of SIUU communications'.
- The quote is a bare noun phrase from a bulleted list: it drops the subject and verb that make it a recommendation, so read alone it does not show that anything is recommended or by whom.
- The rule statement itself is faithful and non-binding ('should include'), authority 'guidance' matches, and the audience/basis scoping (HCP, unapproved-use-scientific) is exactly the guidance's subject matter.
- Determinism 'deterministic' is defensible: a copy of the labeling or a mechanism to obtain it is either present or not, and currency is checked by literal comparison against the current labeling. Severity 'warning' and the Q2 locator are correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Section V Q2 lists, under the lead-in 'FDA recommends that firms include all of the following information as part of SIUU communications:', the item 'A copy of the most current FDA-required labeling (or a mechanism for obtaining this labeling, as appropriate)'. The rule states exactly this recommendation.
- The item is not adjacent to the lead-in sentence in the source.
- The rule keeps the recommendation language ('FDA recommends'). The imperative title does not say 'must'. Authority is guidance.
- Whether a label or a way to get it is present is a presence check, so 'deterministic' fits. The HCP audience and unapproved-use-scientific basis match the SIUU scope. 'warning' severity and the locator 'Section V, Q2' are correct.
- The rule's quote is only the list's lead-in sentence, which several rules share. The quote therefore does not contain the item that establishes this rule. The verifier contract now provides a `lead_in` field for a list item that is not adjacent to its lead-in, so the quote can and should be the item itself.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim an item of the Q2 list, and the rule body correctly frames it as an FDA recommendation.
- The quote is a bare list item with no subject or verb. Its introducing sentence ('FDA recommends that firms include all of the following information as part of SIUU communications:') is separated from it by other list items, an example and footnote text, and the rule has no lead_in. Read alone, the quote does not show that this is a recommendation.
- The title 'Provide a copy of or mechanism to obtain current FDA-required labeling' is a bare command. It turns a non-binding recommendation into an apparent obligation.
- A deterministic check fits: a reviewer can settle it by the presence of a current label or a means to obtain it.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim a Q2 list item, and the lead_in 'FDA recommends that firms include all of the following information as part of SIUU communications:' introduces it. Read together they support the rule, and the rule statement correctly says 'FDA recommends'.
- The title 'Provide a copy of or mechanism to obtain current FDA-required labeling' is a bare command. The source item is only a recommendation in a non-binding guidance.
- Deterministic is acceptable: whether a current label or a way to obtain it is present can be settled by inspection. applies_when (hcp, unapproved-use-scientific) and the locator Section V, Q2 are correct.

Nearby rules

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-027 US-RISK-028 US-SUB-016