Section 6: How should I review advisory statements?

Key Points

• Advisory statements are intended to be informational. They provide information to the product user on such topics as product characteristics and how to reduce risk and maximize efficacy while using the product.
• Advisory statements should not conflict with mandatory statements or use terms that could be interpreted as mandatory or ambiguous. 

Progress Check

• What PR notice provides more information about advisory and mandatory statements?

  PR Notice 2000-5.

• Give three examples of suggestive terms to avoid in advisory statements.

  Should, may, and recommend.

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