A UDI System is a unique numeric or alphanumeric code placed on medical devices to identify them. This identifier must be offered in two forms on labels and packages-plain text and machine-readable. The FDA issues regulations on using UDIs, and they have established a UDI rulemaking process to develop these regulations.
The Unique Device Identification or UDI System Final Rule
The Unique Device Identification System final rule (UDI Rule) requires device labelers (typically, the manufacturer) to:
- Include a unique device identifier (UDI) on device labels and packages (except where the rule provides for an exception or alternative)
- Marked with the UDI directly on any device intended for more than one use and to be reprocessed before each
- Submit device information to the Global Unique Device Identification Database (GUDID)
Is Your Product a Medical Device?
The FDA considers a product to be a device subject to FDA regulation if it meets the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act.
Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or another similar or related article, including a component part or accessory which is:
- (A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).
The Purpose of a UDI
A uniform UID system and its individual UIDs are crucial to public safety efforts. In addition, they provide many benefits to the companies who created the devices and the people who use them.
- Reduce Medical Errors
- Simplify the Integration of Device Use Information Into Data Systems
- Provide for More Rapid Identification of Medical Devices With Adverse Events
- Provide for More Rapid Development of Solutions to Reported Problems
- Provide for More Rapid, More Efficient Resolution of Device Recalls
- Better Focused and More Effective FDA Safety Communication
- Standard Format for Dates Provided on a Device Label
- They Can Be Used in Educational and Informational Materials
- Play an Important Role in Inventory Management
- When Linked With Other FDA Data, Will Help Identify Alternative Devices in the Event of a Shortage
- Will Contribute to Better Detection of Counterfeit Devices
- Identify the Specific Devices Implanted Into Patients To Improve Response to Adverse Event Reporting and Recalls
Compliance dates for UID Rule Compliance have been slowly rolled out to give manufacturers time to implement the changes.
October 19, 2022 Update
The FDA is reminding device industry and unique device identification (UDI) program stakeholders that the enforcement policy described in Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages is applicable to devices labeled prior to September 24, 2023.
Devices labeled on or after September 24, 2023, must comply with all applicable UDI requirements, including the prohibition on the use of certain legacy FDA identification numbers (National Drug Code (NDC) and National Health Related Item Code (NHRIC) numbers) on the label.
Integrated Technology Keeps Your Devices Complaint
Our experience and expertise will keep your devices compliant with the accurate marking of UDI numbers and reporting of the numbers to GUDID. Work with the pros at Integrated Technology.