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FDA Center for Devices and Radiological Health

Is my technology considered a class I, II, III device?

Medical Device Classification Overview
Understand how to determine your device’s classification

FDA Product Classification Database
Search the classification database to learn how similar devices were classified

Does my technology qualify for an expedited regulatory program?

Overview on Breakthrough Device Program
Read an overview of the breakthrough device program to determine if your technology is eligible for expedited review

What standards should I consider when testing my technology?

Overview of Consensus Standards
Read an overview of how to use consensus standards

Standards: Resources and Use in Premarket Submissions
Watch a video on how to use consensus standards in premarket submissions

FDA Consensus Standards Database
Search the database to find consensus standards relevant to a particular technology

Download FDA Guidance: Use of Consensus Standards in Premarket Submissions

How will I get paid for the technology that I develop?

Early Payor Feedback Program
Obtain early payor input on your clinical evidence to support positive coverage decisions

Innovators' Guide To Navigating Medicare
Learn about the Centers for Medicare & Medicaid Services (CMS)

 

Updated Date: 
October 5, 2020