The Challenge of Compliance
There’s nothing more important than patient safety when it comes to the use of medical devices. In an ongoing effort to lower the risk for patients, the U.S. Food and Drug Administration (FDA) has recently implemented a new regulation requiring that all medical devices sold within the United States be documented and tracked.
For medical device manufacturers, this new UDI (Unique Device Identification) regulation requires compliance beginning as early as September 24, 2014. That’s a short amount of time to not only gather the 62 points of data required for each unique device, but to submit them in the correct format to the FDA’s new Global Unique Device Identifier Database (GUDID) for each and every unique product, product version, and product configuration. Although the regulation will first be enforced for Class III Medical Devices, Class II and Class I devices will follow suit in the coming years.
Are you prepared to comply? Underestimating the scope and scale of this regulation could put your U.S. sales at risk. Read more to learn what’s required and how you can achieve UDI compliance.