All campus visitors must be fully vaccinated (boosted). Masks are highly recommended. Instructors & staff are required to submit a daily symptom check. COVID updates.
At the end of the course, students should be able to
- Find the required regulations and guidance documents for device and diagnostic submissions
- Use regulations and guidance documents to outline and construct a variety of device submissions
- Appreciate the role that regulatory strategy play in the submissions process, for US device submissions
- 510(k)s: Traditional, special, abbreviated
- Panel and Pre-submission preparation
- Warning letter responses
- Medical Device reports and IDEs
In order to obtain maximal benefit, this hands-on course requires substantial out-of-class work on a submission project, where you will be crafting a 510K. Please plan your course schedules accordingly.
- Save Your Seat
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- Accessing Canvas
Learn more about gaining access to your course on Canvas in our FAQ section.
Accessibility and Accommodation
For accessibility questions or to request an accommodation, please visit Access for Students with Disabilities or email the Extension registrar.
Finance Your Education
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Estimated Cost: TBD
Course Availability Notification
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