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CDRH Regulatory Educational Materials

The Division of Industry and Consumer Education (DICE) at the FDA’s Center for Devices and Radiological Health (CDRH) has developed the resources below to provide you the most current and accurate information about medical devices and radiation-emitting products.

CDRH Learn

How to Get Your Electronic Product on the U.S. Market

Watch this How to Get Your Electronic Product on the U.S. Market module on the FDA YouTube channel.

Device Advice

Recently Posted Program Updates

• Breakthrough Devices Program (08/03/2022)
• Accreditation Scheme for Conformity Assessment (ASCA) (06/07/2022)
  • ASCA-Accredited Testing Laboratories (09/01/2022)
  • Testing Laboratories: How to Participate in the ASCA Pilot (06/28/2022)
  • Accreditation Bodies: How to Participate in the ASCA Pilot (06/07/2022)
• 510(k) Third Party Review Program (08/19/2022)
  • Review Memos for Third Party 510(k) Reviewers (08/19/2022)
• eMDR System Enhancements (08/30/2022)
  • Coding Resources for Medical Device Reports (08/22/2022)
  • Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) File (08/22/2022)

Watch Regulatory Education for Industry (REdI) 2022 Annual Conference!

Missed the live broadcast? Check out the recordings

• Plenary Session: COVID-19: What’s Next for FDA (06/06/2022)
• Devices Track (06/08/2022)
• Device Track (continued) (06/09/2022)

Contact DICE

If you have questions about DICE, please Contact Us – Division of Industry and Consumer Education (DICE).