FDA launches new database for medical device

May 12, 2015 – The U.S. Food and Drug Administration (FDA) launched a new database to allow the public to access, search, and download information that medical device manufacturers submit to the FDA about their medical devices.  The database, FDA’s Global Unique Device Identification Database, is available at the AccessGUDID website (http://accessgudid.nlm.nih.gov/).  According to the FDA: “Unlike drugs, many medical devices currently do not have a unique identifier that clearly distinguishes one product from another.  But this is changing.  The UDI [unique device identifier] system will provide a consistent and standard way to identify medical devices throughout their distribution and use by health care providers and patients.”  As part of this process, the FDA will require each medical device to display its UDI on its label and packaging (and on the product itself for certain devices).  The FDA is phasing in this UDI system through 2020, focusing currently on the highest risk medical devices.  As it will be updated daily, this database will provide the public with the most up-to-date information submitted to the FDA for each medical device.

By: Frederick C. Millett