The Food and Drug Administration Amendments Act of 2007 establishes a unique device identification (UDI) system to monitor medical devices through their use and distribution. In 2013, this rule was finalized. Implementation of the FDA UDI system improves the overall health and safety of patients through device monitoring. It also helps to spur on new medical device innovations.
As this rule is phased in, device labels will need to include identification data that is both human- and machine-readable. Information will also need to be registered with the FDA’s Global Unique Device Identification Database (GUDID).
Here are basic tips for complying with the FDA’s Medical Device Identification Rule:
- The UDI for each product must be labeled in plain text and in a format that uses automatic identification and data capture (AIDC).
- Identification must be marked directly onto a device that is intended to have more than one use.
- Information must adhere to the same format used in international standards and practices.
- Devices must be registered to the FDA’s GUDID. Users of medical devices will then be able to access information from this database.
Ensuring that your products are labeled correctly is the key to successfully registering them in the GUDID. But there is no one, cookie-cutter solution for satisfying marking, labeling, and verification regulations. Customized solutions ensure compliancy.
Turn to an integrator with the experience to fit your company’s needs and budget for:
- Industrial marking solutions that follow GS1 Data Matrix barcode nomenclature
- 2D data matrix scanners that are engineered for UDI data collection compliance
- 2D data matrix software that offers parsing and validation capabilities in line with FDA guidelines
The integrator that provides hardware and software solutions to take into account FDA UDI criteria is ID Integration, Inc. We’ll provide you with the marking hardware systems necessary to create indelible identification codes for your products: Direct Part Marking (DPM) using chemical etching or laser equipment, or permanent identification affixed to permanent, tamper-proof labels.
ID Integration’s BarCodeOS ® software suite turns any 2D matrix scanner into a “smart scanner”—No need to bother with 300-page manuals. This software works right out of the box for efficient validation and error reporting. Browse our site for more information, and call our experts at to (425) 438-2533 to receive answers to your specific UDI compliancy questions.