The FDA’s UDI Rule Is Coming…Ready?

Tue, 07/23/2013 - 5:05pm
Scott Pugh, Vice President, Solution and Service Innovation, Verify Brand

The FDA UDI rule will standardize the way the medical device industry identifies its products, which is a foundational step toward utilizing companies like Verify Brand who offer higher value, more complex solutions. Engaging these solutions is critical to helping manufacturers secure supply chains, deter counterfeiting, and ensure patients have access to safe medical devices.

Today, Verify Brand supports medical device manufactures in areas related to UDI compliance, including adoption of GS1 standards, standardization and integration of product data, and interfacing with third parties, like the FDA Global Unique Device Identification Database (GUDID). In the long term, medical device manufacturers can expand their utilization of secure unique identification solutions, like Verify Brand’s VB Enterprise platform, to streamline serialization and track and trace capabilities.

As medical device manufacturers are being subjected to an increasing number of similar UDI regulations worldwide, VB Enterprise’s Message Management Service (MMS) provides the necessary data mapping and transformation needed to meet these regulations with a centralized solution. Such a solution will enable medical device manufacturers to realize an increased ROI by minimizing their time and resource investments each time they leverage MMS to meet a new UDI related regulatory requirement.


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