Right as everyone left for a (sweltering) Fourth of July break, the Center for Devices and Radiological Health (CDRH) released its proposed Unique Device Identification (UDI) rule. The Food and Drug Administration (FDA) has been under increasing pressure from Congress and other stakeholders to finish this proposed rule (required under the 2007 FDAAA legislation) and released the proposed rule just as President Obama was getting ready to sign legislation requiring them to do so.
The basic idea behind UDI — simple in concept but complex in implementation — is that essentially all medical devices of any complexity would have a unique alphanumeric coded identification number on its label and, in some cases, on the device itself.
Feel like you have heard a similar version of this story before? You are not alone. The idea behind UDI is not unlike the "SNI" — or standardized numerical identifier — for prescription drug packages. See FDA Guidance: Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages (March 2010). The UDI rule seems conceptually consistent with FDA's continued interest in technologies that could enhance patient safety and supply chain security, an issue that is also top-of-mind in the U.S. Congress, where leading Democrat and Republican members of both chambers have called for federal legislation to enhance downstream pharmaceutical distribution chain security to be enacted this year.
The core concept behind the UDI rule is that, with some exceptions for products such as non-prescription class I devices (e.g., tongue depressors, bandages and crutches), each medical device (including diagnostics) will have a two-part alphanumeric code UDI on its label for use by health care providers, patients, FDA, industry and others.
Part 1 of the UDI is the "device identifier" which identifies the manufacturer (or "labeler") and the version or model of the device.
Part 2 of the UDI is the "production identifier" which sets forth the lot or batch number, serial number (if applicable), expiration date and date of manufacture.
The device identification number would be in both plain language and machine readable form. In order to learn about the device, the user would use the UDI number to access the device specific information contained in a new, to be created Global Unique Device Identification Database (now called the GUDID — another new acronym to learn).
Manufacturers will be required to submit device specific information to the GUDID. Information within GUDID may include manufacturer information, trade names, sterility status, PMA/510(k) number, the Global Medical Device Nomenclature code (GMDN) and recall history of the device.
Together, the number on the device and the information in the GUDID will permit any user, health care provider or patient to access basic information about the system, identify key safety issues and, perhaps, to report issues.
In the proposed rule, FDA identifies key outcomes it hopes to achieve with the UDI system. These include:
- Reduction in medical errors as health care providers can now access basic information about any device
- Ability to unambiguously identify any device and provide access to information
- Rapid identification of devices with reported safety issues or which are subject to recalls
- Faster correction of device problems and more accurate and rapid recall completion
As can be imagined given the complexity and heterogeneous nature of the device market, the rule is highly complex (the notice is more than 160 pages) with many different rules for specific product types and packaging configurations. Some key special provisions in the draft rule include:
- The UDI generally is required to be on the label of a device, but for certain devices it must also be on the device itself. This is true for implantable devices and reusable devices (e.g., infusion pumps, certain surgical instruments and some test equipment).
- A separate UDI may be needed for convenience kits, and in many cases, the elements of the convenience kit will need their own UDI.
- Combination products regulated as devices (i.e., with a device primary mode of action) will need a UDI. Unless physically or chemically combined, the device elements of many drug or biologic regulated products may need a UDI.
- Different package configurations will need separate UDIs. For example, if a device is packaged individually and then also routinely sold in packs of five, the individual product and the "5 pack" will each need a separate UDI.
The implementation mechanics for industry and FDA are quite complex. The GUDID database needs to be created, and standard formats must be agreed upon. A device and manufacturer unique coding system is needed. Currently, FDA proposes that a third party be accredited by FDA to actually assign numbers. At some point, this system needs to be linked into the event reporting system (i.e., MDR system) and the recall system.
FDA is also clear that the UDI is in addition to other numbering or coding systems, such as Universal Product Codes (NPC) and National Health-Related Item Codes (NHRICs). FDA intends for this system to be compatible with international systems.
FDA is currently planning on a phased implementation of the rule with the implementation clock starting whenever the rule is issued as a final regulation by FDA. If past history is any guide, it is very unlikely the rule will be finalized this year.
- Class III devices will need UDIs one year after the rule is final.
- Class II devices will need UDIs three years after the rule is final.
- Class I devices (to the extent covered) will need UDIs five years after the rule is final.
The proposed UDI rule is currently available on FDA's website. Once published in the Federal Register, there will be a 120-day comment period on the substance of the rule and a 60-day comment period on the "information collection requirements" (i.e., paper work reduction and regulatory burden questions).
Given the potential impact of the rule on medical device manufacturers and providers, companies should review this closely and consider commenting on the proposal.