Life Sciences Blog

Understanding FDA Exemptions to Unique Device Identification (UDI) Requirements

Aug 2, 2023 | Medical Devices, Unique Device Identification, US FDA

The Food and Drug Administration (FDA) has implemented the Unique Device Identification (UDI) system to enhance patient safety, improve post-market surveillance, and facilitate the identification of medical devices. The UDI system requires manufacturers to assign a unique code to each medical device and submit relevant information to a centralized database. There are several benefits to manufacturers and the entire supply chain when products are visible in FDA GUDID, including more efficiency in handling recalls, and better informed prescribing decisions by healthcare providers. UDI labeling also helps in the fight against counterfeit devices.

FDA recognizes that not all medical devices can easily comply with these requirements. As a result, certain exemptions to UDI requirements have been put in place to balance regulatory needs with practical considerations.

To make your UDI discovery process more accessible, we have created a helpful flowchart to help you define if your medical device is exempt. Where does your portfolio appear in regards to exceptions or requirements?

Hover over the images to see their descriptions.
To download the flowchart, please click here


While exemptions offer certain manufacturers relief from UDI requirements, it is essential to note that patient safety remains the FDA’s top priority. Manufacturers seeking exemptions must still comply with other safety and performance regulations to ensure their products are safe.

At Reed Tech, we specialize in medical device product data requirements for global health authorities. UDI can become overwhelming without experienced guidance. If we can help with questions about FDA, EUDAMED, or other emerging regulators, don’t hesitate to reach out. Our team of experts can help you set a UDI strategy for initial data submissions and ongoing maintenance.

Email us: [email protected] or call +1-215-557-3010

About LexisNexis Legal & Professional

LexisNexis Legal & Professional® provides legal, regulatory, and business information and analytics that help customers increase their productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 150 countries with 11,300 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers.

About LexisNexis Reed Tech

LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.

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