On 3 July 2012 the U.S. Food and Drug Administration (FDA) released its proposed rule1 on the Unique Device Identification (UDI) system that would apply to all medical devices (devices) minus certain categorical exceptions. The proposed rule would fulfill the statutory requirement of the FDA Amendments Act of 2007.
At this point, FDA has only issued a proposed rule and is in the process of collecting comments from the public. The due date for comments is 7 November 2012 and the final rule is expected to be released by May 2013.2
What exactly is a UDI?
Under the proposed rule, a UDI would identify certain key information about the device when used in conjunction with an FDA-maintained database. The UDI would be a plaintext numeric or alphanumeric code placed on device labeling that can be used to identify the specific device model, the device labeler, and the current production information for the device including the lot/batch, serial number, expiration date and date of manufacture, and sterilization requirements. Where a device is subject to the UDI requirements, the device labeler would be required to provide this information to FDA for inclusion in the Global Unique Device Identification Database (GUDID).
The UDI would also be presented in the form of a bar code, radio-frequency identification, near-field communication, or other code that automated identification and data capture (AIDC) technology would be able to read. The AIDC requirement allows users to quickly and accurately identify devices. By scanning or entering the UDI into the GUDID, pertinent, non-confidential information regarding the device would be available.
UDIs would be issued by FDA accredited third-party agencies that would charge a small fee. FDA may also serve as an issuing agency. The accreditation process will ensure that each UDI is unique no matter which agency issues the UDI.
Where would the UDI appear?
If the proposed rule is enacted, a UDI must be placed on the labeling and packaging of all medical devices, with exceptions for certain categories of devices. Furthermore, the UDI would also have to be directly marked onto the device for three main categories of devices where FDA has concerns that the device could become separated from its labeling: (1) implantable devices; (2) devices used more than once and sterilized before each use; and (3) stand-alone software that is a “device” under §201(h) of the FD&C Act.
Exemptions from UDI requirements
Under the proposed rule, the following categories of devices would be exempt from all UDI requirements:
- Class I devices sold at retail establishments or directly to hospitals
- Class I devices that are exempt from the requirements of the Quality Systems Regulation, 21 C.F.R. Part 820
- Devices used solely for research, teaching, or chemical analysis, and not intended for any clinical use
- Custom devices
- Investigational devices
- Veterinary medical device
- Devices intended for export from the United States
- Devices held by the Strategic National Stockpile
- Device constituent part of a combination product, provided that it is not possible for the device constituent part to be used except as part of the use of the combination product
- Devices that are packaged in a convenience kit, provided that the device is intended for a single use, and the outer package is labeled
- Shipping containers, but the device packages within the shipping container would be subject to all UDI labeling requirements unless an exception applies
- Additional case-by-case labeling exceptions
In addition, a company can request an exemption from the UDI requirements or propose an alternative arrangement by filing a notice with FDA explaining why the labeling requirements are not technologically feasible or why an alternative method of labeling provides more accurate, precise, or rapid identification of the device or better ensures its safety or effectiveness.
Finally, companies can exempt themselves from the direct marking UDI requirement if the device meets a defined exemption or the company determines that the direct marking of a product "interferes with safety or efficacy" of the device (e.g., direct marking would interfere with the structural integrity of a bone screw) or is "not technologically feasible" (e.g., direct marking bone cement, which is packaged as an amorphous substance). Notably, the proposed rule does allow means for very small companies to seek an exception from direct marking requirements where the capital investment in technology to allow direct marking so exceeds the benefit of direct marking under "not technologically feasible" exemption. As currently drafted, however, the proposed rule provides FDA with significant discretion in deciding which firms meet this exception in terms of what companies are considered small firms as well as the expenditure/benefit considerations.
To be excepted from direct marking requirements under the "interferes with safety or efficacy of the device" or "not technologically feasible" categories, the company would need to submit a notice to FDA providing the rationale for the exception to the direct marking requirements. While FDA is not currently planning to formally respond to these exception notifications, the agency may request additional information.
Timeline of implementation
UDI labeling requirements would take effect:
- One year after publication of the final rule for class III devices;
- Three years after publication for class II devices; and
- Five years after publication for class I devices and devices not classified into class I, II, or III.
For applicable devices, direct marking requirements will go into effect two years after the date the general UDI requirements are in effect for each particular class of devices.
Implications on industry
The UDI proposed rule envisions a system of total lifecycle management for medical devices by allowing manufacturers, healthcare providers, and regulatory authorities to unambiguously identify devices and, with little effort, obtain pertinent information on a device.
FDA believes that UDIs will improve the performance of field actions (e.g., recalls, customer notifications) and adverse event reporting. Currently, the number of available devices in the market, some of which can be hard to identify even with their packaging, can make it very difficult to accurately identify the exact device which is subject to a field action or is linked to an adverse event. This not only poses a detriment to public health, but to the manufacturer as well. UDIs provide healthcare providers with rapid information on the current status of a device. Moreover, UDIs may permit manufacturers to limit the size and cost of a field action by being able to remove only the specific devices that were impacted as opposed to removing an entire lot, assuming that the UDI manufacturer attaches detailed information to the device’s UDI. UDIs are also expected to reduce medical errors by allowing healthcare providers to scan a device’s UDI before using it to ensure that the specifications match the medical orders and are not contraindicated to the patient’s condition (e.g., using a device that has latex on a patient with a latex allergy).
Exploiting the full range of benefits the UDI system may provide will depend on whether hospitals and other healthcare providers have sufficient IT systems established that can readily integrate the information that the UDI provides. Widely adopted and functional IT systems would also allow both providers and manufacturers to have better inventory tracking and management of devices.
The proposed rule presents new burdens upon the industry. For instance, manufactures will have to pay fees to obtain a UDI from the issuer, and setting up systems to properly mark labels, packages and, in some instances, devices themselves with a UDI will add additional manufacturing costs. Coming into compliance with the rule, once enacted, may require a manufacturer to purchase new machinery and IT systems, redesign labels, and makes changes to the company’s quality system.
FDA has set up a staggered schedule of gradual implementation of UDIs to minimize any immediate impact from the rule. It will likely take firms a number of months, however, to integrate these new requirements into their production process and potentially longer for implantable device manufacturers subject to direct marking requirements.