2 Introduction

This document provides the best practices and recommendations to configure Combination Products and generate PMSR reports for Combination and Non-Combination Products using FDA E2B(R2) 2.2 profile.

FDA has published a Final Guidance on the Post-Marketing Safety Reporting (PMSR) for Combination Products guidelines in July 2019 regarding reporting of Combination Products marketed in the United States.

FDA has also published a Technical Specification Document for Preparing and Submitting Electronic ICSRs and ICSR Attachments in February 2020, which covered the following requirement on Similar devices reporting:

Combination Product Applicants for combination products containing device constituent parts should submit Malfunction reports to FDA for otherwise reportable malfunctions, for both devices and device constituent parts of combination products marketed outside the U.S. by that applicant that are the same as, or similar to, the device constituent part of the applicant’s U.S.-marketed combination product if the malfunction is likely to occur in the U.S. marketed combination product.

As per FDA, Combination Product Applicants should submit PMSRs consistent with the requirements of the combination product with compliance date July 31, 2020 for reporting ICSR to FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) to report ICSRs.