New Product Codes for Certain Medical Devices Granted Emergency Use Authorization (EUA)

Use the new product codes when reporting an adverse event to the FDA or importing a device.

If your email program has trouble displaying this email, view as a webpage. New Product Codes for Certain Medical Devices Authorized for Emergency Use under EUAs The U.S. Food and Drug Administration (FDA) has created new product codes for certain medical devices authorized for emergency use under Emergency Use Authorizations (EUAs). An applicable product code has been assigned to each authorized device category. The product codes are listed in the tables for each category of devices that have EUAs. The categories of devices are available on the Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices page. See New Product Codes Using the New Product Codes EUA holders and device user facilities can use the new product codes for medical devices granted Emergency Use Authorization for COVID-19. Use the new product code whenever a product code is needed or requested, such as when reporting an adverse event in a medical device report (MDR) or importing a device. It is important to include the appropriate product code for the medical device to: Ensure the FDA can adequately monitor and analyze reportable adverse events for devices granted an EUA. Help the FDA track imports of EUA devices. Questions? If you have questions about product codes for devices under EUA, contact the Division of Industry and Consumer Education.

Follow us on Twitter at @FDADeviceInfo Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA