If you are a manufacturer or labeler of a Class 2 device in the US, then products manufactured or labeled after September 24, 2016 must be in compliance with FDA’s Unique Device Identifier (UDI) regulation.
If you’re behind on this process, AlvaMed can help. We have experience helping clients large and small successfully navigate UDI compliance.
The idea behind UDI is to generate a number that can be associated with each medical device for quick reference and identification. Compliance with the UDI regulation includes two key components:
- The application of the UDI to the device labeling (and in some cases, the device itself); and,
- The entry of UDI information into the publically accessible GUDID database.
Each UDI is comprised of a Device Identifier (DI) and Production Identifier (PI). The DI is intended to identify the particular version or configuration of a device and is assigned by one of FDA’s accrediting agencies. The PI provides additional information specific to the manufacture of the device, such as lot numbers, serial numbers or expiration dates. UDIs must be included on the product label in both human readable (e.g. plain text) and machine readable (e.g. barcode) formats. For devices intended to be used more than once and intended to be reprocessed before each use, direct marking of the UDI on the device is also required (however the compliance date for direct marking of Class 2 devices is September 24, 2018).
The general steps for establishing the required UDIs are outlined below:
- Determine which products/configurations/accessories/kits require UDI
- Select and register with the FDA accrediting agency of your choice
- Obtain the necessary DIs from the accrediting agency
- For each DI, determine what PI information will be included based upon the product labeling
- Select your barcode format and modify labeling as required to accommodate
- Prepare the necessary infrastructure to support the UDI process, including:
−Updates to quality system processes to ensure DIs are created and maintained properly
−Updates to label creation, printing and inspection processes
−Installation and validation of label printing equipment as needed
In parallel, you must register with the FDA GUDID database. Once a test account is created, you will submit sample data to ensure it meets all upload requirements. For each product that requires a UDI, there are over 50 available fields of data that need to be entered, so this exercise should not be taken lightly. Once reviewed and accepted by FDA, the test account will be converted to a production account. Given the expected bolus of submissions as the deadline approaches, slow response times can be expected from FDA.
For additional information, visit the FDA homepage for UDI: Unique Device Identification