Safe Medical Devices Act – Medical Device Reporting: An Overview

A publication prepared by the United States Department of Health and Human Services is included in this manual.  It provides a brief overview of the regulation.  Summary tables provide a quick reference for reporting requirements.

FDA - Medical Device Reporting

Appendix A – MedWatch Report 

Appendix B: Medical Device Reporting Semi-annual User Facility Report 

Appendix C MDR Baseline Report