Course Content
Introduction and Background
Welcome to the course! Before we begin, let's cover some of the essential background needed to get the most out of this course.
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Welcome!
00:54
Instructor Tips
01:37
Code of Federal Regulations
Understand the legal basis for medical device regulation in the US
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FDA and Scope
01:12
Title 21 of the CFR
02:36
Device Classification
Learn how devices are defined and classified in the US, and the tools we can use to determine classification of our device
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Medical Device Definitions
04:39
Device Classification
09:44
Device Classification: Answers
04:22
FDA Regulatory Pathway
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FDA Regulatory Pathway
01:45
510(k) Submissions
Let's explore the most commonly used FDA submission: the 510(k)
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Basic Overview 510(k) Process
00:55
Concept of Substantial Equivalence
02:56
Intended Use vs Indications for Use
02:39
Identifying a Predicate
05:50
Substantial Equivalence Workflow
02:59
Types of 510(k)s
04:54
510(k) structure
02:27
513(g) Mechanism
Learn about the handy 513(g) mechanism: when and how to use it
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513(g) Mechanism
03:58
De Novo Submission
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De Novo sumbissions
03:52
De Novo Strategy
02:36
Premarket Approval (PMA)
High-risk devices require a more sttingent submission, the PMA. Let's find out more.
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Premarket Approval (PMA)
01:58
FDA Cleared vs FDA Approved
02:08
Quality System Requirements
Brief introduction to quality management systems and Good Manufacturing Practices
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FDA QSR
03:17
Submission Process and Costs
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Submission Process and Costs
01:47
Post-Submission
Get the latest updates on FDA news and requirements
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Post-Submission Process
04:14
Device and Registration Listing
05:30
Emergency Use Authorizations
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Emergency Use Authorizations
02:48
Final Tools
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Final Tools and Resources
00:22
Primer: US FDA Medical Device Regulations
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