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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 products.

Device Advice

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

• Total Product Life Cycle Advisory Program (TAP) (02/26/2024)
• eSTAR Program (02/05/2024)
• Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP) (01/31/2024)
• Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions (01/31/2024)
• Exporting Medical Devices (01/02/2024)
  • Devices Not Exported from the United States (01/02/2024)
  • How to Request Export Certificates or Permits and How to Submit Simple Notifications (01/02/2024)
  • Exporting Medical Devices: Frequently Asked Questions (FAQs) (01/02/2024)
• Device Master Files (12/06/2023)
• Device Registration and Listing (11/29/2023)

CDRH Webinars

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

• Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance (01/11/2024)
• Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program (12/12/2023)
• Immediately-in-effect guidance: Antimicrobial Susceptibility Test Systems Devices – Updating Breakpoints in Device Labeling (12/05/2023)

This year, CDRH launched a new town hall series on medical device sterilization and held these events:

• FDA’s Modifications Guidances and the Use of Device Master Files in Reviews (02/29/2024)
• Discussion of Premarket Submission Expectations and Additional Considerations for Sterility Review (02/07/2024)
• FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (01/26/2024)
• Overview of Sterilization Landscape and Role of Ethylene Oxide (01/10/2024)

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