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Medical Device Reporting (MDR) - Forms and Instructions

MedWatch Reporting Form 3500 (Voluntary Adverse Event Reporting Form)
Instructions for FDA Form 3500
Fillable PDF Form
MedWatch Reporting Form 3500A (Mandatory Adverse Event Reporting Form) For use by: IND Reporters, manufacturers, distributors, importers, user facilities personnel)
Abbreviated Instructions for FDA Form 3500A Specific to Medical Device Reporting
Mandatory MedWatch Reporting Form 3500A: Instructions
Mandatory MedWatch Reporting Form 3500A - Fillable PDF Form
Mandatory MedWatch Reporting Form 3500A: Codes Manual
Medical Device Reporting Annual User Facility Report - Form FDA3419*
Instructions for Completing the Medical Device Reporting Annual User Facility Report, Form FDA3419
Medical Device Reporting Baseline Report - Form FDA3417*
Instructions for Completing Form 3417 - Baseline Report

*These reports can be filled in on your PC. You may then print them out and mail to FDA

Updated April 1, 2008

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