This DRAFT guidance addresses how to comply with the final rule on postmarketing safety  reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the “combination product PMSR final rule,” “final rule,” or “rule”).  The rule describes how to comply with PMSR requirements for combination products that have received FDA marketing authorization.  Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct reporting requirements, including reporting triggers and timeframes.  The final rule addresses the application of these regulatory requirements to combination products to ensure consistent and complete reporting while avoiding duplication.

Section II of the guidance provides general information on combination products, how FDA regulates combination products, and a summary of the combination product PMSR final rule.  Section III provides an overview of which entities are subject to the final rule and what safety reporting requirements apply to such entities.  Section IV provides more detailed discussion of specific combination product PMSR report types.  Section V provides guidance on where, how, and when to submit PMSR reports to FDA.  Section VI provides hypothetical scenarios that illustrate how to comply with certain combination product PMSR requirements.  While this guidance focuses on the requirements of the combination product PMSR final rule, it also addresses associated topics including postmarketing safety reporting requirements applicable to entities not covered by the rule (see Appendix 3).

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance documents describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word “should” in agency guidance documents means that something is suggested or recommended, but not required.

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