Do not link directly from approved-use promotional pages to SIUU pages

Where this comes from

Section V, Q3, item 2, Example 2 · page 22. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…oved uses of its medical products to HCPs online through websites, FDA recommends that SIUU communications be on a separate web page from the web page that hosts promotional communications about the approved uses of the medical product and that the web page for the SIUU communications clearly identifies those communications through the clear and prominent presentation of the disclosures recommended in this guidance. FDA also recommends that firms not include direct links from web pages that host promotional communications about approved uses to web pages that host SIUU communications. Example 3: If a firm chooses to share information about both approved and unapproved uses of its medical products to HCPs through email messages, FDA recommends that email messages used to share SIUU communications be separate from email messages used to share promotional communications about approved uses of the medical product and that the email messages used to share SIUU communications clearly identify those …

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.