FDA Extends UDI Compliance Deadline for Some Medical Devices

The FDA’s Center for Devices and Radiological Health (CDRH) is granting a compliance extension of some of the UDI labeling requirements for some non-sterile implantable medical devices, which were otherwise subject to the September 24, 2105 compliance deadline.The new compliance deadline is September 24, 2016 for devices that meet ALL of the following criteria:

Compliance Deadline Extension Criteria

1. classified with primary product codes and regulations listed on the letter to implant labelers
2. single use implants, and
3. intended to be sterilized (or cleaned and sterilized) before use. Most of the devices that meet these three criteria are supplied non-sterile by the manufacturer

USDM Life Sciences will provide more details about the extension at a live webinar on January 15, 2015. USDM’s Jay Crowley, who had primary responsibility for the development and implementation of FDA’s UDI system will lead the presentation.