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Medical Device Regulation
Medical Device Regulation
Objectives
Course Navigation
Definition of a Medical Device
Do You Have a Medical Device?
Intended Use Examples
What is a Medical Device?
Special Considerations: Digital Health Technologies as Medical Devices
Your Medical Device
The Role of Regulations in the Innovation Pathway
Innovation Pathway
Your Medical Device
Research Regulation
Significant and Non-significant Risk
Who Determines Risk?
Test Your Knowledge
Special Considerations: Diagnostic Devices
Your Medical Device
FDA Marketing Regulation
FDA Marketing Regulation
Intended Use and FDA Classification
FDA Clearances and Approvals
FDA Clearances and Approvals
Special Considerations: Diagnostic Devices
Your Medical Device
Regulatory Timeline and Cost
Regulatory Timeline and Cost
Regulatory Timeline and Cost
Average 510(k) Product Timeline
Average 510(k) Product Cost
Your Medical Device
Summary
References
Medical Device Regulation
Special Considerations: Health IT
Digital Health Technologies as Medical Devices
Special Considerations: Diagnostic
Exempt Devices
Special Considerations: Diagnostic Clearance
Diagnostics Approval Pathways
Medical Device Regulations Updated
Resources
doc
Questionnaire - Regulatory Pathway for Your Device
link
Device - Not a Device
link
Device Advice
link
Significant vs. Non-significant Risk
link
510(k) Submission Process
link
Policy for Device Software Functions and Mobile Medical Applications
link
De Novo Classification Request
link
PMA Process
link
Tool for Software Related Projects
link
Medical Device User Fees
link
Algorithms Guidance
link
How to Search for a Predicate Device
Medical Device Regulations Updated
Medical Device Regulations Updated
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