Newly Launched FDA Website Tracks Medical Devices

Newly Launched FDA Website Tracks Medical Devices

Newly Launched FDA Website Tracks Medical Devices


The U.S. Food and Drug Administration (FDA) has announced the launch of its online Global Unique Device Identification Database, AccessGUDID, which allows the public to track medical devices through unique identifiers. Through this site, company-submitted information can now be looked up by consumers. Modern Healthcare reports that the site was launched three years after Congress called for medical devices to be tracked through unique identifiers. The hope is that consumers, healthcare providers and manufacturers can more readily identify and report side effects associated with a device. The website also aims to be an important resource when a recall is issued, hopefully allowing the issue to handled for effectively.

The online database was created under a provision of the 2012 Food and Drug Administration Safety and Innovation Act. In 2013, the FDA issued a final rule. The phased implementation starts with requiring manufacturers of all Class 3 devices to include a UDI. All medical devices must have a UDI by 2020.

According to FDA estimates, there are about 50,000 serious adverse events associated with medical devices each year, leading to roughly 3,000 deaths.

There has been some criticism of the system, Modern Healthcare reports. Some say the unique identifiers requirement would be expensive for providers who already have issues with transitioning to electronic health records systems. However, the FDA asserts that UDIs would allow for a more thorough method of tracking medical devices and assist with sharing data across various systems, which has been an issue up until now.

This entry was posted in Legal News and tagged , , , . Bookmark the permalink.


© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.