FDA Reporting for Safer Medical Products



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9AM - 5PM CST (M-F)

Faculty: Donna L Atherton RN, MSN, NP and Carol Pierini MA


Successful Completion: Complete entire module, complete the exam with a passing score of 80% or better, and complete the evaluation form.


Estimated Time to Complete Activity: 60 minutes.


CEUs: HIPAA Exams is authorized by IACET to offer 0.1 CEUs for this program. CEU Information


Free Certification of Completion available instantly for download or printing upon successful completion.


This 60-minute course broadens your knowledge of mandatory and voluntary medical device reporting as put forth by the Center for Devices and Radiological Health in the U.S. Food and Drug Administration. It covers what must be reported, by who, and how to file the reporting.


Course includes a video and audio component with stand-alone exam

How to Purchase


Learning Objectives

  • Identify medical device reporting requirements of adverse events to the FDA and the manufacturer.
  • Describe the steps and requirements for reporting to the FDA 
  • Discover how the FDA enforces Medical Device Reporting

Target Audience

This course is designed for those in the manufacturing/production of medical devices/pharmaceuticals field.

Table of Contents

FDA Reporting for Safer Medical Devices (FDA MDR)

Table of Contents:

  • FDA Medical Device Reporting
  • Legal Notice
  • Course Purpose and Learning Objectives
  • FDA MDR Background
  • MDR Medical Device Reporting
  • Mandatory Medical Device Reporting
  • Who Are Mandatory Reporters?
  • Mandatory Medical Device Reporting: Manufacturer
  • Mandatory Medical Device Reporting: Importers
  • Mandatory Medical Device Reporting: Medical Device User Facility
  • FDA MedWatch Program
  • FDA MedWatch
  • FDA MDR Reporting Requirements
  • FDA MDR Other Reporting Requirements
  • MDR Reporting Requirements: User Facility
  • MDR Reporting Requirements: Manufacturer
  • FDA Enforcement of MDR Requirements
  • MedSun: Medical Product Safety Network
  • MedSun Program
  • AERS: Adverse Event Reporting System
  • Summary
  • End of Course Quiz


Course Content Example 1:

Mandatory Medical Device Reporting


The Medical Device Reporting (MDR) regulation contains mandatory requirements for manufacturers, importers, and medical device user facilities to report specific device-related adverse events and product problems to the FDA


Who Are Mandatory Reporters?


Mandatory Reporters include:Manufacturers of medical devices, Importers of medical devices, Medical Device user facilities


The FDA encourages voluntary reporting about adverse events (AEs) by the following:

  • Health care professionals
  • Patients
  • Caregivers
  • Consumers


Course Content Example 2:

FDA Enforcement of MDR Requirements


Criminal Penalty Authority

Failure to comply with MDR requirements is a prohibited act under the Food, Drug, and Cosmetic Act (FD&C Act).

  • Criminal Penalties may be up to a $1,000 fine and one-year imprisonment for the first offense if the offense was unintentional
  • Criminal penalties may be up to $10,000 and three-years imprisonment for subsequent offenses or for intentional offense.


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