2019-08-27 DICE Quarterly Newsletter - Vol. 1 Issue 3

Get the Latest 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 or updated the resources below to provide you the most current and accurate information about medical devices and radiation-emitting products.

Device Advice CDRH recently posted these pages in Device Advice: Getting a Humanitarian Use Device to Market (05/16/2019) Expanded Access for Medical Devices (06/21/2019) Class I/II Exemptions (07/01/2019) Third Party Review Program (7/31/2019) Medical Device User Fee Amendments (MDUFA) (08/07/2019) Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S.(08/08/2019) CDRH Learn CDRH recently released the following educational modules in CDRH Learn: Postmarket Activities Overview of Medical Device Reporting (08/22/2019) Medical Device Reporting for Mandatory Reporters (08/22/2019) View CDRH Learn List of Modules

Note: CDRH Learn modules translated into Chinese are now located here. New Address: MDUFA Small Business Certification Request The mailing address for the Small Business Program has changed.  Please send requests to: FY2020 (or FY2019*) MDUFA Small Business Qualification Small Business Certification Program 10903 New Hampshire Avenue Building 66, Room 5305 Silver Spring, MD  20993 U.S.A. *Indicate the Fiscal Year for which you’re applying.  FY2019 Status is good until September 30, 2019. Medical Device Webinars and Stakeholder Calls CDRH hosts regulatory webinars and stakeholder calls for the medical device industry. View past recordings and upcoming listings.