DICE Quarterly Newsletter - Vol. 1 Issue 4

Get the Latest Regulatory Educational Materials from CDRH

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

CDRH recently released the following educational modules in CDRH Learn: Start Here/The Basics! How is CDRH Structured? (09/30/2019) Is My Product a Medical Device? (09/30/2019) How to Study and Marked Your Device Introduction to the Premarket Approval Application (PMA) Program (09/30/2019) Premarket Approval Application (PMA) Program: Postapproval Requirements (09/30/2019) How is My Medical Device Classified? (09/30/2019) Case Study: How is My Medical Device Classified? (09/30/2019) Would you like to see a new topic? Please give us your feedback! View CDRH Learn List of Modules

Device Advice

CDRH recently posted these pages in Device Advice: How to Find and Effectively Use Predicate Devices (09/04/2019) De Novo Classification Request (09/06/2019) Framework for the Safety and Performance Based Pathway (09/10/2019) Frequently Asked Questions (FAQs) About the Accreditation Scheme for Conformity Assessment (ASCA) Pilot (09/20/2019) Accreditation Scheme for Conformity Assessment (ASCA) (09/30/2019)

Join Us for the next CDRH Industry Basics – November 5

Please join the FDA experts on November 5, 2019 for the next CDRH Industry Basics Program, a live workshop with questions and answer.  No fee and no registration needed. 1:00-2:00 pm ET: 513(g) Requests for Information 2:00-3:00 pm ET: Custom Device Exemptions On the day of the program, use this link to join. Medical Device Webinars and Stakeholder Calls CDRH hosts regulatory webinars and stakeholder calls for the medical device industry. View past recordings and upcoming listings.