FDA Guidance for Industry: Compliance Policy for Combination Product Postmarketing Safety Reporting

FDA Guidance for Industry: Compliance Policy for Combination Product Postmarketing Safety Reporting

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.