The rule and guidance document for Unique Device Identifiers ("UDI") on medical devices and some combination product that contain devices has been released.

The UDI system is intended to provide benefits such as greater accuracy in the review and analysis of adverse events, reduction in medical errors, enhancement of device analysis and post market surveillance, improvement of recall efficiency, establishment of a global distribution chain, and, hopefully, lead to the development of a medical device identification system that is understood and potentially implemented world-wide.

The UDI requirements will be implemented in phases according to the rule, timed at 1 year, 2 year, 3 years, 5 years, and 7 years after the publication of the final rule. The waves are based on risk classification, with Class III devices phased in during the earlier phases, Class II devices in later phases, and Class I in final phases. The detailed break-down of which classes fall within each phase can be found at the FDA's UDI Resource Page.

The implementation of the UDI requirements for manufacturers is fairly straight-forward, but will take some work especially for companies with large portfolios of products. It may behoove many manufacturers, even of Class II devices, to come into compliance as soon as practical, even if their device does not require compliance for 2 or 3 years after the publication of the final rule.

-RTK

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!