Disclose the FDA-approved use(s) and labeling limitations

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

Rule

FDA recommends that firms include, as part of SIUU communications, a statement disclosing the FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling.

Check

Confirm the communication states the approved indication(s) and any labeled limitations of use. A violation is omitting the approved use(s) or omitting stated limitations of use.

Where this comes from

Section V, Q2 · page 18. 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:

… A statement that the unapproved use(s) of the medical product has not been approved by FDA and that the safety and effectiveness of the medical product for the unapproved use(s) has not been established For example, a statement that "[Medical Product X] has not been approved by FDA for use in [Condition Y], and the safety and effectiveness of [Medical Product X] for [Condition Y] has not been established." A statement disclosing the FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling A statement disclosing any limitations, restrictions, cautions, warnings, or precautions described in the FDA-required labeling about the unapproved use(s) Similarly, medical devices have a very high failure rate in their first prototype tests, with a reported 90 percent of medical devices failing in their first prototype tests (see Intertek (2010). The Top 10 Reasons Medical Devices Fail Product Certification T…

Open the original at page 18 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
- Supported: the Q2 list includes 'A statement disclosing the FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling', and the rule restates it faithfully with the recommendatory 'should'.
- The quote is a bare list item that drops the stem 'FDA recommends that firms include all of the following information as part of SIUU communications', so it has no subject or verb and does not establish a recommendation on its own.
- Atomic as the source frames it: one statement covering approved use(s) together with labeled limitations of use.
- Determinism 'deterministic' is correct (the statement is present or absent, and its content is compared literally against the FDA-required labeling). Severity 'warning', authority 'guidance', the Q2 locator and the HCP / unapproved-use-scientific scoping 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 'A statement disclosing the FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling'. The rule restates this word for word with 'FDA recommends'.
- The item is separated from the lead-in by the first list item and its example.
- Approved uses and their labeled limitations of use form one list item in the source, so the rule is atomic. Presence is deterministic. Scope, severity and locator 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 the second Q2 list item. The rule body correctly frames it as 'FDA recommends that firms include'.
- A deterministic check fits because the presence of the approved use statement and the labeled limitations of use settles it.
- The quote is a bare list item without a subject. The introducing sentence is separated from it by the first list item and its example, and there is no lead_in.
- The title 'Disclose the FDA-approved use(s) and labeling limitations' is a bare command. It also says 'labeling limitations', while the source says 'limitations of use specified in the FDA-required labeling', which is narrower than the separate item about limitations, restrictions, cautions and warnings.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim from Section V, Q2. It is an item in the list introduced by the lead_in 'FDA recommends that firms include all of the following information as part of SIUU communications:', and the lead_in is verbatim. Read together, they establish the recommendation.
- The rule statement correctly keeps it as a recommendation ('FDA recommends that firms include...').
- The title 'Disclose the FDA-approved use(s) and labeling limitations' is a bare command. The source is non-binding: FDA recommends this. The title overstates it.
- The check leaves out an exception the source states in Q4. When an SIUU communication has no firm-generated presentation and includes an unabridged CPG or reference text in its entirety, covering a wide range of medical products and not primarily focused on the firm's products, 'FDA does not expect a firm to include' a statement disclosing the FDA-approved use(s), including any limitations of use. It recommends a more general statement instead. As written, the check would flag communications that FDA says need not include this statement.
- Deterministic is acceptable. Whether a statement of the approved use(s) and the labeled limitations of use is present can be settled by comparing the piece with the labeling.
- The severity of warning and the hcp / unapproved-use-scientific scope are justified. The locator 'Section V, Q2' is correct.

Nearby rules

US-DISC-005 US-DISC-006 US-DISC-007 US-DISC-008 US-DISC-009 US-RISK-024 US-RISK-025 US-RISK-026 US-RISK-027 US-RISK-028 US-SUB-016