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

What database is used for reporting medical device adverse events?

The database used for reporting medical device adverse events is the Manufacturer and User Facility Device Experience (MAUDE) database. This database houses the Medical Device Reporting (MDR) submissions made to the FDA by mandatory reporters (manufacturers, importers, and device user facilities), as well as voluntary reporters such as healthcare professionals.

Why does the FDA use a passive system for medical device reporting?

The FDA uses a passive system for medical device reporting primarily because it relies on voluntary reporting from various stakeholders, such as manufacturers, healthcare professionals, and consumers, to gather information about adverse events, device failures, and potential safety issues. This passive surveillance system allows the FDA to monitor device performance and collect post-market data, which informs their decision-making processes on device regulation and potential safety concerns.

The FDA's Manufacturer and User Facility Device Experience (MAUDE) database is used to collect and store reports related to medical device adverse events. While the system is based on voluntary and mandatory reporting, the passive nature of this surveillance system means that data interpretation should be cautious, given potential under-reporting, inaccuracies, and lack of verification.

Despite its limitations, the passive surveillance system helps the FDA gather a broad range of information regarding medical device-related adverse events and safety concerns, contributing to their ongoing efforts to ensure public health protection.

Medical device reporting (MDR): how do I report medical device problems?

There are several steps you can follow to report medical device problems under the Medical Device Reporting (MDR) system:

  1. Identify whether the problem should be reported as a mandatory or voluntary report. If you are a manufacturer, importer, or device user facility, you are required to report adverse events, malfunctions, and other device-related issues. Healthcare professionals, patients, and consumers can also submit voluntary reports.
  2. If you are a mandatory reporter, you must submit the appropriate FDA Form 3500A electronically through the Electronic Submission Gateway (ESG) within the specified time frame, which depends on the severity and nature of the event. For voluntary reporters, including healthcare professionals and consumers, submit FDA Form 3500B through MedWatch — the FDA's Safety Information and Adverse Event Reporting Program, either electronically or by mail.
  3. Provide detailed information about the event, device, patient involved (if applicable), and any actions taken after the event.

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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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