FDA Finalizes New System to Identify Medical Devices

According to an FDA news release posted on September 20, 2013, the U.S. Food and Drug Administration (“FDA”) is launching a new system for identifying high-risk medical devices such as hip and knee implants.  The agency announced that its new Unique Device Identification System (UDI) will provide a consistent and simpler way to identify medical devices. According to the FDA, the 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.

How the New Unique Device Identification System Works

The new UDI system will require that device manufacturers assign a unique number called a “unique device identifier” to their medical devices.  This number will include product-specific information such a lot numbers, expiration dates and manufacturing dates.  The unique device identifier and device information will be maintained in a publicly searchable database administered by the FDA.

UDI System*Graphic from FDA website

Timeline for Implementation of the New Unique Device Identification System

High-risk medical devices labeled as Class III devices by the FDA will be required to have unique device identifiers on their label and packaging and the corresponding device information submitted to the new database within one year.  Moderate-risk or Class II device manufacturers will have three years and Class I device manufacturers will have 5 years to implement the new unique device identifiers.

Read the FDA News Release:

Free Case Review

Get a Free Consultation. No Fees Unless We Win. We’re Here 24/7

News & Media