FDA Regulatory Requirements for Medical Devices (United States)
This course provides an overview of the United States FDA Regulatory Requirements for Medical Devices.
Whether you’re navigating premarket submissions, managing labelling and registration, or preparing for post-market obligations, this training equips you with the knowledge you need to ensure compliance.
You’ll explore FDA device classification, key regulatory pathways like 510(k), De Novo, and PMA, and gain clarity on labelling rules, Unique Device Identification (UDI), registration and listing, and adverse event reporting. The course also touches on current FDA trends, digital health considerations, and the FDA’s role in Global Harmonization efforts.
Our eLearning is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
Overview of our U.S FDA Regulatory Requirements for Medical Devices
What's covered on our FDA Regulatory Requirements Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
Eoin Philip Kelly
Michelle Keane
At the end of this short course, successful learners will be able to:
- Understand the FDA’s Regulatory Framework for Medical Devices, including Device Classification and Applicable Market Authorization Pathways
- Identify the requirements for premarket submissions such as 510(k), De Novo, PMA, and related clinical investigation processes
- Apply FDA rules for labelling, Unique Device Identification (UDI), and Establishment Registration and Device Listing
- Recognize Post-Market Regulatory Obligations, including adverse event reporting, recalls, and surveillance requirements
- Navigate current FDA initiatives, digital health considerations, and the agency’s role in Global Regulatory Alignment
This course is for individuals or organizations who want to understand the United States FDA Regulatory Requirements for Medical Devices
Successful completion of the course examination will entitle each Learner to receive a digital Certificate of Completion.
In order to successfully complete this course, each Learner will need to:
- Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Have 5 or more that need training?
We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.
Frequently Asked Questions
No, this micro-credential is only available for groups of 10 or more, or for licensing (annual subscription) on your organization’s Learning Management System (LMS). For more information, visit our licensing page or complete our contact us form and a member of our team will be in touch.
Once you have successfully completed the training, including all assessments, your certificate will be available within 1 business day. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print from your learner dashboard.
Please note: no certificates are available without full payment on file.
The eLearning duration provided is based on the average amount of time it takes an average learner who is new to the subject/topic, and has been independently verified by a globally recognized professional body, i.e. CQI and IRCA, RAPS, or Exemplar Global.
In reality, the amount of time it takes to complete the eLearning will vary depending on your prior experience, knowledge & learning style.
To complete this course successfully, you will need to fully complete each module and obtain 70% or higher in the applicable assessment(s).
All graded assessments are MCQ-based.
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
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What Our Learners Are Saying
4
Average Rating
2 global ratings
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More material on QMSR would be usefull.
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Brilliant format, really easy to follow, and the course content was well written.
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