What is UDI?
As part of the FDA Amendments Act of 2007, FDA was required by Congress to develop a unique device identification (UDI) system for medical devices.
A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device (lot, serial number or expiration date).
Another component of the UDI system is an FDA-controlled database that will include a standard set of identifying elements for each UDI. Most of this information will be publicly available so that users of a medical device can easily look up information.
AdvaMed has worked extensively with the agency over the past several years to help maximize the usefulness and value of any potential UDI system as a postmarket tool and to lessen the implementation burdens on industry.
AdvaMed believes that, if implemented and used appropriately, a UDI system can provide more accurate and useful postmarket surveillance. That is why we have supported establishment of a UDI system, provided it takes into account the diversity of medical devices and provides information useful to understanding their postmarket performance.
AdvaMed is committed to working with FDA and other stakeholders to move forward in implementing an effective UDI system that takes into account the diversity of medical devices and provides information useful to understanding their post-market performance.
Once fully implemented, a UDI system could also potentially:
- Facilitate more accurate reporting, reviewing and analyzing of postmarket device data by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries;
- Generate postmarket data that could be used to support premarket approval or clearance of new devices and new uses of currently marketed devices;
- Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies; and
- Lead to the development of an internationally harmonized medical device identification system.
FDA Final Rule
FDA’s final UDI rule, published on September 23, 2013, addresses many of the concerns industry raised in the proposed rule. Key provisions of the final UDI rule include:
- No direct marking of implants will be required.
- Product held in inventory at the time of the effective date for the specific class of device will be given an additional three years to deplete the inventory.
- Single-use devices sold within a multi-pack will only need the UDI on the multi-pack.
- The ISO date format will be used; although FDA is insisting on including the day of the month for expiration dates when expiration date testing does not include the day of the month.
- Class III device manufacturers can petition to extend the one-year implementation deadline based on public health and supply disruption issues.
|7/19/12||FDA Proposed Rule on Unique Device Identification System [Docket No. FDA-2011-N-0090]||Technology & Regulatory Affairs||Regulation|
|11/7/12||Comments on Docket No. FDA-2011-N-0090, Proposed Rule, Unique Device Identification System||Technology & Regulatory Affairs||Comments|
|10/25/12||Comments on Information Collection Issues under the Paperwork Reduction Act of 1995 - Proposed Rule, Unique Device Identification System [FDA-2011-N-0090]||Technology & Regulatory Affairs||Comments|
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