Hipaa exams

FDA Reporting for Safer Medical Products

FDA Reporting for Safer Medical Products

Only $24.95

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
System Requirements
CEUs: HIPAA Exams is authorized by IACET to offer 0.1 CEUs for this program.


Broaden 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.

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


  • 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


Feature image

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:

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.


  • Instant Certificate Of Completion Printing Upon Successful Completion Of FDA Reporting for Safer Medical Products
  • Free Retakes on Exam Until You Pass
  • Instant Access: 100% Online - Access 24/7 from Anywhere
  • No Recurring Fees


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