DICE Quarterly Newsletter - Vol. 2 Issue 2 – Division of Industry and Consumer Education (DICE) | FDA

Contact Us – Division of Industry and Consumer Education (DICE) | FDA

Get the Latest Regulatory Educational Materials from CDRH: Special COVID-19 Edition

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 on the Spanish section of CDRH Learn: Empieza aquí/Los básicos! – Start Here/The Basics! Una Introducción a las Regulaciones de Dispositivos Médicos de la FDA – An Introduction to FDA’s Regulation of Medical Devices (03/10/2020) Actividades de postventa - Postmarket Activities Resumen de la Regulación del Sistema de Calidad – Overview of the Quality Systems (03/10/2020) Exportación de Dispositivos Médicos – Exporting Medical Devices (03/10/2020) Resumen Sobre los Reportes de Dispositivos Médicos – Overview of Medical Device Reporting (03/10/2020) 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: 510(k) Format Tips (01/15/2020) Classify Your Medical Device (02/07/2020) 510(k) Third Party Review Program (03/11/2020) Case for Quality (03/27/2020) Exporting Medical Devices Frequently Asked Questions (FAQs) (04/23/2020) 510(k) Program Pilots (04/24/2020) PMA Application Contents (06/03/2020) Medical Device Consumer Page

CDRH recently revised and updated the page Resources for You: Consumers (Medical Devices). The page now features these sections: Popular Topics Medical Device Safety How Do I Report a Problem with a Medical Device Consumer Topics,  grouped from A-C and D-Z Resources for You

COVID-19 Medical Device Resources CDRH has provided several resources to help you understand the medical device regulatory requirements during the COVID-19 public health emergency. Contacts for Medical Devices During the COVID-19 Pandemic Medical Devices and the COVID-19 Pandemic Emergency Use Authorizations Virtual Town Hall Series for COVID-19 Diagnostic Tests – Upcoming listing and past recordings Learn more about educational resources for you.