FDA Release Final Rule on Unique Device Identifiers (UDI)

The Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. It also applies to certain combination products that contain devices and to devices licensed under the Public Health Service (PHS) Act (e.g., donor screening assays).

A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety. In developing the proposed UDI system, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies.

For more information, review the full article on the FDA's web site:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm?utm_source=Members-Only Updates
Portford's own DocuNECT Medical Device Tracking system is completely flexible when it comes to assigning device IDs and can fully support the UDI guidelines as outlined by the FDA.

If you use our Medical Device Tracking solution and want to find out more information then don't hesitate to reach out to us at: support@portfordsolutions.com.