2 Introduction

This document lists best practices and recommendations for generating electronic medical device reports (eMDR).

In July 2019, the Food and Drug Administration (FDA) published guidelines on Post-Marketing Safety Reporting (PMSR) for combination products. These guidelines refer to the 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 for combination products with the compliance date set as July 31, 2020 when reporting:

• ICSRs to FDA Adverse Event Reporting System (FAERS);
• ICSRs reported with Electronic Medical Device Reporting System (eMDR).