lunes, 1 de febrero de 2016

Global Unique Device Identification Database (GUDID): Accounts for Class II Device Labelers

Beginning February 1, 2016, FDA will accept GUDID account requests from labelers of class II devices.
FDA’s experience and feedback from industry indicate that device labelers often take a number of actions to organize, collect and validate data—before they get a GUDID account or submit device identifier (DI) records. We strongly encourage all device labelers to take such actions to ensure their readiness to meet UDI requirements and streamline the GUDID submission process. Suggested steps to prepare for GUDIDcan be found on the UDI web site.
We also encourage you to watch two new training modules made available through CDRH’s Industry Basics program. The video covers two topics: 1) UDI System Regulatory Overview and 2) Requesting a GUDID Account. Additional broadcasts about how to submit data to GUDID are coming soon!
We remain committed to providing the medical device industry, health care systems, clinicians and patients the assistance and information needed to implement and use UDI successfully. For additional information, please see or contact us at the FDA UDI Help Desk.

Food and Drug Administration
Center for Devices and Radiological Health

No hay comentarios: