Understanding UDI Requirements for Medical Devices
The Food and Drug Administration (FDA) requires that most medical devices have a unique device identifier (UDI). This helps ensure that the device has been properly manufactured, tested, evaluated, and approved by the FDA. How do these requirements impact your product? Let’s take a closer look at these UDI requirements for medical devices.
Timeline for Compliance with UDI Requirements
The FDA began phasing in its UDI requirements in 2014 starting with Class III devices, these included implants, life-supporting, and life-sustaining devices. Per FDA regulation 21 CFR 801.20 every medical device and device label “shall bear a UDI that meets the applicable requirements of” 21 CFR 801 and 803. The FDA issued an update in October 2022, reminding the device industry 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 and the Code of Federal Regulations (CFR) are applicable to devices labeled prior to September 24, 2023. Devices labeled on or after September 24, 2023, must comply with all pertinent UDI requirements.
What is a Unique Device Identifier?
The UDI must be presented in two forms, easily readable plain-text and automated identification and data capture (AIDC) technology. It includes two parts: the device identifier (DI) which identifies the specific version or model of a particular device; and the production identifier (PI), which provides information about when and where it was manufactured, as well as its expiration date (if applicable). This information can help track down potential safety issues related to certain products more quickly and efficiently than ever before.
Who Needs to Comply with UDI Requirements?
Any company that manufactures medical devices must comply with UDI requirements set forth by the FDA. Even if your product is exempt from other FDA regulations, you may still be required to include a UDI if it meets certain criteria. For example, if your product is intended for use in an invasive procedure or has been previously recalled due to safety concerns, then it must have a unique device identifier per FDA regulations.
Having a unique device identifier helps companies adhere to FDA regulations while also ensuring that their products are safe for use by consumers. By understanding when their products need to have FDA compliant UDIs per the FDA’s timeline, companies can ensure that they are able to produce quality medical devices that meet all the necessary requirements set forth by the agency and protect their customers from potentially dangerous products. Adhering to these regulations will help keep consumers safe and provide peace of mind knowing that they are using only quality medical devices.