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 0.10 CEUs for this program. CEU Information
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.
- 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
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
- End of Course Quiz
Course Content Example 1:
Who Are Mandatory Reporters?
Mandatory Reporters include:
The FDA encourages voluntary reporting about adverse events (AEs) by the following:
- Manufacturers of medical devices
- Importers of medical devices
- Medical Device user facilities
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 Online FDA Reporting for Safer Medical Products Training Course
- • Free Retakes on Exam Until You Pass
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