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Industry and Consumer Education

The Division of Industry and Consumer Education (DICE) at the FDA’s Center for Devices and Radiological Health (CDRH) develops educational resources about medical devices and radiation-emitting electronic products.

Device Advice

Device Advice explains medical device laws, regulations, guidances, and policies, across the entire product lifecycle. CDRH recently posted these program updates:

• Guidance Documents (Medical Devices and Radiation-Emitting Products) (11/03/2023)
• Total Product Life Cycle Advisory Program (TAP) (10/18/2023)
• eSTAR Program (10/02/2023)
• Device Registration and Listing (09/29/2023)
• Accreditation Scheme for Conformity Assessment (ASCA) (09/19/2023)
• Breakthrough Devices Program (09/14/2023)
• Biocompatibility Assessment Resource Center
  • Basics of Biocompatibility: Information Needed for Assessment by the FDA (09/07/2023)
  • Glossary of Biocompatibility Terms (09/07/2023)
  • Biocompatibility Evaluation Endpoints by Device Category (09/07/2023)
  • Biocompatibility Evaluation Endpoints by Contact Duration Periods (09/07/2023)
  • Component and Device Documentation Examples for Test Articles or Previously Marketed Devices (09/07/2023)
  • What Should I Put in a Test Report?(09/07/2023)
• A History of Medical Device Regulation and Oversight in the United States (08/21/2023)
• Tips for Submitting Comments on CDRH Guidance Documents (08/16/2023)

CDRH Learn

CDRH Learn is our multi-media educational resource. CDRH recently posted these educational modules:

Start Here/The Basics! | Device Registration and Listing

• Device Registration and Listing: An Introduction – Part 1
• Device Registration and Listing: An Introduction – Part 2

How to Study and Market Your Device | Cross-Cutting Premarket Policy

• CDRH Portal Overview and Feature Walkthrough

These educational modules feature the latest navigation tools:

• QR codes: for hyperlinks included in presentations. Click while watching!
• Sections: Click icon to jump between sections

CDRH Webinars

CDRH recently held these webinars on recent guidances, regulations, and various policies:

• Breakthrough Devices Program Updated Final Guidance (11/14/2023)
• Final Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (11/02/2023)
• Proposed Rule: Medical Devices; Laboratory Developed Tests (10/31/2023)
• CDRH’s New Draft Guidances to Continue to Modernize the 510(k) Program (10/26/2023)
• Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process – Final Guidance (10/12/2023)
• Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder, Draft Guidance (09/14/2023)
• Qualification of Medical Device Development Tools (09/12/2023)

Check out this 2-minute video to learn more about educational resources we provide for you. If you have questions about DICE, please Contact Us – Division of Industry and Consumer Education (DICE).