About this Course
This course will broaden your knowledge of FDA Reporting for Safer Medical Products.
You'll learn about FDA Reporting for Safer Medical Products. This 60-minute course expands your knowledge of medical device reporting as described by the Center for Devices and Radiological Health in the U.S. Food and Drug Administration. It includes what must be reported, who is responsible for reporting, and how to file the report.
Upon passing your final exam, we'll provide a certificate of completion for your records. Plus, we're authorized by IACET to offer 0.1 CEUs for this program.
What You Get
Certificate of Completion
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Content is updated and current
What You'll Learn
- 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 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
When Does My Course Expire?
Your course will expire one (1) year after you purchase it (the date you submit payment), unless the course itself indicates otherwise.
How Quickly Will I Get My Certificate of Completion?
Once you finish your course and pass any required exams, you can print your certificate of completion right away.
What Can I Do If I Lose My Certificate?
If you lose your certificate of completion and need a new one, you can contact customer service at (877) 881-2235 or firstname.lastname@example.org.
What If I Need a Refund for My Training Course?
If for some reason you are not happy and would like a refund, send us a request within 72 hours of purchase. Here are the eligibility requirements you must meet:
- Your purchase was made no more than 72 hours prior to your refund request.
- You have NOT
- Attempted any portion of a test or exam.
- Requested or been issued a certificate of completion.
- Completed 50% or more of the purchased course.
If you meet all of these criteria, submit your refund request in writing via email to email@example.com with a proof-of-purchase receipt and an explanation for why you are requesting a refund.
You can find more information about our refund policy here.
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