FDA Center for Devices and Radiological Health
Getting started with CDRH
Communicating with CDRH
Contact CDRH's Division of Industry and Consumer Education (DICE)
Phone: 1(800) 638-2041 or (301) 796-7100
Email: DICE@fda.hhs.gov
Activities to Support Medical Device Innovators
Get general help on a variety of device topics
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
My technology is...
What is the right premarket submission for my technology?
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
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)