Regulatory Information

Compliance Policy for Combination Product Postmarketing Safety Reporting

Immediately in Effect Guidance for Industry and Food and Drug Administration Staff

Guidance Document (PDF - 59.6KB)

This guidance document is intended to assist Combination Product Applicants who are subject to the Combination Product Postmarketing Safety Reporting Final Rule (hereafter “combination product PMSR final rule,” “final rule,” or “rule”), issued on December 20, 2016 (81 FR 92603), and codified in 21 CFR Part 4, Subpart B.  This guidance document discusses FDA’s compliance policy for the rule.  FDA does not intend to enforce certain requirements under the rule, specifically 21 CFR 4.102(c) and (d), 4.104(b)(1) and (b)(2), and 4.105(b), for a period of time as discussed further in section III below.  FDA intends to delay enforcement of these provisions to ensure that Combination Product Applicants have sufficient time to update reporting and recordkeeping systems and procedures, including their information technology systems, to comply with these requirements, and in doing so, have sufficient time to consider the recommendations and technical specifications that FDA intends to provide through guidance to support compliance.  For all other provisions of 21 CFR Part 4, Subpart B, FDA intends to enforce (or continue enforcing) the requirements per its usual policies as of the compliance date provided in the final rule. 

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances 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 means that something is suggested or recommended, but not required.

Page Last Updated: 07/18/2018
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