Updated Sept 24 2020.
As of September 24, 2020 Class I medical devices needed to meet the FDA’s Unique Device Identification Final Rule. However, that date was postponed by the FDA in July with the publication of a new Policy Guideline document. That means the FDA will not begin enforcing the UDA Final Rule on these devices until September 24, 2022. By this new date,
manufacturers must make the mandated identification and labeling changes to these devices and register them in the FDA’s Global Unique Device Identification Database (GUDID).
Given the volume of Class I devices—and the fact that the implementation of the rule started several years ago—this has been quite the project for manufacturers. Adding the impacts of COVID-19 on the entire life sciences sector, the FDA found it prudent to give manufacturers more time to comply.
One small caveat is that finished Class I and unclassified devices on the market that were manufactured and labeled prior to September 24, 2018 would still be excepted from the Final Rule until September 24, 2021. Given the new enforcement date in 2022, manufacturers no longer need to worry about this provision.
Unique Device Identification Overview
For most devices, a UDI is an identifier that contains a single Device Identifier (DI) that identifies the specific version or model of a device and the labeler of that device, plus one or more Production Identifiers (PI). Valid PIs include:
- Lot number
- Expiration date
- Date of manufacture
- Serial number
- Version number (for software devices only)
But Class 1 devices are recognized by the FDA as “lower risk” devices, relative to the higher classes, so the UDI Final Rule includes several exceptions that mostly apply to Class 1 devices. Most importantly, Class I devices are not required to include any production identifiers in their UDI, and they may use a Universal Product Code (UPC) as their UDI. Use of a UPC is sufficient to fulfill all of the UDI labeling requirements. The UPC exception is important because some Class 1 devices are sold over the counter at retail, but the exception applies to all Class I devices regardless through which channels they are sold.
Many Class 1 devices fall into the category of Single Use Devices (SUD). An SUD is any device that is intended for one use, or on a single patient during a single procedure. The Final Rule includes an exception from the direct marking requirement to SUDs in any class.
Learn more about medical device compliance and identification: