A few years back, the Food and Drug Administration (FDA) saw how the world was quickly evolving. The data explosion or the data revolution was upon us, creating the need for a regulatory framework that would offer a range of benefits to the healthcare industry. This framework would address issues and concerns on a local level as well as on a global level; some of the benefits included:

  • Creating more detailed and accurate reporting
  • Mitigating medical errors
  • Trace and trackability
  • Common identifier to manage recalls
  • Securing the supply chain and counterfeit prevention
  • Creating a global language around medical device identification

In 2013, the FDA introduced the final rule for Unique Device Identification (UDI) regulation. This mandate requires all medical devices sold in the United States to be labeled with a UDI along with specific product data submitted and stored in the Global Unique Device Identifier Database (GUDID). To effectively transition the manufacturers to the final rule mandate, the FDA decided on a ‘phased’ approach. By using the classification of the device (Class I, II, III) the FDA phased in the implementation over a seven year period. Rapidly approaching is the September 24, 2016 deadline for Class II devices (life sustaining/supporting) to achieve compliance.

What does this mean for Class II Devices and how can these organizations find a solution?

The FDA’s UDI initiative is a government mandate and there will be repercussions to those who are not compliant. Besides extensions and exceptions to the final rule, companies will be subjected to fines that accrue over time, as well as the possibility of lost revenue due to the fact that products without a UDI cannot be sold in the U.S. market. This mandate is ultimately in place for the safety of the industry and patients, but the byproduct is serving as a catalyst of change and driving the healthcare industry towards global standardization.

There are companies that can help the industry comply to the UDI regulation by having direct proprietary feeds to the FDA’s GUDID. Understanding all of the requirements, attributes, exceptions, and even who is responsible for the product are all issues that need to be understood. This is not a small task for any company and takes organizational commitment to data governance and data quality programs.

Committed to embracing the challenge, healthcare companies are fostering the opportunity to streamline internal systems and integrate global standards and data syndication through vehicles such as the Global Data Synchronization Network™ (GDSN®). We are seeing healthcare companies of all sizes preparing for regulatory initiatives by utilizing solutions that provide a seamless process to collect, store, manage, and distribute product information. By streamlining internal processes and transmitting data from a single source of truth these companies are able to exchange data at a global level.

As big as the world is, it is shrinking. Data and the dissemination of data have created a need and a want for transparency. Regulatory mandates such as UDI and other global regulatory initiatives are making companies think and act outside the box of how their internal systems can support the aggregation and exchange of data. As an advocate for trusted product information exchange, I strongly recommend that the healthcare industry embrace GS1 standards and data vehicles such as the GDSN. These proven and successful frameworks help improve supply chain management and support product transparency and compliance. At the end of the day, it keeps companies honest on behalf of the safety of their patients.


Todd Simons is a healthcare industry expert for 1WorldSync.