The FDA recently released its final rule on Unique Device Identification (UDI) for medical devices. Here’s some information on the new rule and how it could affect you.
UDI is unique identification applied to medical devices. If you are a supplier of medical devices, you can adapt to UDI fairly easily with in your existing identification and data management processes. For the rest of you, the final UDI rule issued in the Federal Register on September 24, 2013 may present a few challenges. This rule is effective December 23, 2013 with certain provisions having later compliance dates. Some phased implementation of this rule will take place over a period of 7 years.
The FDA received and reviewed approximately 270 submissions of comments on the amended proposed November 19, 2012 FDA rule, from approximately 225 sources including: individuals (health care professionals, academics, consumers, and others), organizations (consumer groups, hospitals, health care associations, military and government sources, and others), and private industry (device manufacturers, industry associations, distributors, and others). These comments provided approximately 1,700 pages of feedback and commentary concerning the proposed rule.
The final rule seeks establish “a system to adequately identify devices through distribution and use,” and requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement.
The rule is intended to establish the UDI as a data key that leads to information which can be analyzed, used to establish controls and accessed/disseminated quickly. Using UDI as a data key will:
The labeler must:
Under the UDI system established by this rule, the health care community and the public will be able to identify a device through a UDI that will appear on the label and package of a device. The UDI will also function as the key that can be used to obtain openly accessible information about the medical product from the GUDID. The GUDID will not include patient information.
The rule “fulfills a statutory requirement of section 519(f) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(f)) that directs FDA establish a unique device identification system for medical devices. The rule also added requirements from section 614 of the Food and Drug Administration Safety and Innovation Act (FDASIA), including a deadline for final rule publication and when the rule must apply to devices that are implantable, life-supporting, or life-sustaining.”
The technical requirements of a UDI consist of 1) a device identifier that corresponds to the version or model of the device and the labeler of the device and 2) A production identifier that provides variable information, such as the lot or batch, the serial number, expiration date or the date of manufacture.
It should be noted that only the combination of serial number and the device identifier will provide a UDI that is traceable to an individual instance of an item. In response to a question about the lack of individual traceability, the FDA responded that UDI by lot or batch provides identification that enables inquiry and action for items “manufactured under essentially the same conditions” and “intended to have uniform characteristics and quality within specified limits” where sufficient for its intended use.
Two items worth noting are:
One of the biggest changes between the proposed rule and the final rule is the addition of several exceptions to the UDI requirement as listed below: