Medical Device Reporting (MDR) Forms for Device Manufacturers - How to Complete Form 3500A, Form 3417 and Form 3381
Food and Drug Administration
Education
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Food and Drug Administration Center for Devices and Radiological Health
Medical Device Reporting (MDR) Forms for Device Manufacturers - How to Complete Form 3500A, Form 3417 and Form 3381 AVA19844-VBNB1
The Medical Device Reporting (MDR) Regulation requires the use of three forms for medical device manufacturers in reporting to FDA under the regulation. These forms include Form 3500A, Form 3417 Baseline Report, and Form 3381 Annual Certification.
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