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:
- Reduce medical errors
- Simplify the integration of device use information into data systems
- Provide for more rapid identification of medical devices with adverse events
- Provide for more rapid development of solutions to reported problems
- Provide for more rapid and more efficient resolution of device recalls
- Better focused and more effective FDA safety communication
- Other benefits to be determined
- Standard format for dates provided on a device label
The labeler must:
- Submit product information concerning devices to FDA’s Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative.
- Ensure the label and device package of each medical device includes a UDI in a plain-text version and in an automatic identification form that uses data capture (AIDC) technology.
- The UDI shall be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use
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:
- The rule requires all UDIs to be issued under a system operated by an FDA-accredited issuing agency. The rule provides a process through which an applicant would seek FDA accreditation as an issuing agency even if an organization is already an ISO accredited issuing agency.
- The rule does not establish a single AIDC data carrier requirement. Instead, it allows any data carrier, such as a bar code symbology, which may dramatically impact users hoping to gain value from the underlying technology. To truly leverage UDI, the infrastructure must support the data carrier and the lack of a common data carrier will impact hospitals, health care providers and others throughout the supply chain.
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:
- A Class I Device labeled with a Universal Product Code (UPC) may use the UPC as its UDI.
- The device constituent part packaged within a combination product from the requirement that its label bear a UDI, if the combination product bears a UDI.
- Devices contained within a convenience kit bear a UDI, but does require the label and each device package of every convenience kit to bear a UDI.
- A Class I Device that FDA has by regulation been exempted (but for the continuing requirement for recordkeeping) from the good manufacturing practice requirements.
- Individual single use devices, regardless of class, except that this exception is not available for any implantable device. The device package containing these individual devices is not excluded, and must bear a UDI.
- The final rule provides that a device packaged within the immediate container of a combination product is excluded from the requirements if the combination product bears a UDI.