- FDA is now drafting a proposed rule to implement a unique device identification system. We expect to publish the proposed rule during 2010.
- Because the draft has not been completed and approved for publication, this summary provides only a limited, broad outline of proposals being considered for inclusion in the rule. We cannot provide greater detail at this time. Instead, this summary focuses on the objectives and principles that are guiding development of the proposed rule.
Objectives of the Rule
Fulfill statutory directive to establish a unique device identification system. Section 226 of the Food and Drug Administration Amendments Act of 2007, P.L. 110-85, amended the Federal Food, Drug, and Cosmetic Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The requirement reads:
Unique Device Identification System
(f) The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.
Reduce medical errors involving medical devices by
- Providing a single, globally-accepted source for positive identification of medical devices. Health care professionals and patients will no longer have to access multiple, inconsistent, and incomplete sources in an attempt to identify a device, its key attributes, and a designated source for additional information.
- Ensuring the adequate identification of the device through its distribution and use. The system established by this rule will require the label of every medical device to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device. Labeling requirements will be phased in over a period of some years.
- Providing rapid access to key attributes relating to the device. The UDI system will allow rapid retrieval of information from a specialized database that focuses on the identification of devices.
- Simplifying integration of information on device use into medical records. The UDI system will be designed to ensure compatibility with electronic health records.
- Providing a means of added depth to patient and physician educational materials without adding greater complexity. Inclusion of UDI keys in educational materials will provide another means for readers to obtain additional information concerning devices, without any loss of focus on the core messages.
Provide for more rapid resolution of device problems, by -
- Making it possible to more rapidly identify devices involved in adverse events. UDIs will be available for inclusion in adverse event reports, allowing greater accuracy in reporting, and more rapid aggregation of related reports.
- Providing for more rapid resolution of confirmed problems. UDIs will allow FDA to more rapidly collate and analyze problem reports and identify the most-appropriate solution to a particular concern. UDIs will also allow FDA more accurately target safety alerts, recalls, and other corrective actions on the specific devices that are of concern. At the same time, devices not implicated by the problem will be less likely to be “swept up” in an over-broad attempt to remove potentially hazardous devices.
- Provide a single, globally-accepted “key” that can be used to link and integrate existing government, hospital, and corporate data bases that relate to medial devices. UDIs will allow for improved procurement, inventory management, and accounting. The existence of a “key” to link disparate data bases will allow creative new medical and business applications, and synergy among those applications.
- Meet other Federal agencies’ needs for a single, consistent means of identifying medical devices. CMS, DoD, and DVA are examples of Federal agencies that have expressed interest in a national UDI system.
- Reduce the costs of moving medical devices in international commerce by allowing more rapid, accurate identification of devices at the border. A UDI will make it easier for Customs to confirm that a device has appropriate FDA clearance and may be imported.
Principles Guiding Development of the Proposed Rule
FDA’s proposed UDI system should be based on existing, broadly-accepted international standards. Basing the UDI system on existing, accepted standards will help ensure that UDIs will be broadly accepted for use by the U.S. healthcare community and in international commerce.
Burdens should be limited to the essential minimum required for an effective system. UDI data requirements should not overlap data submitted to meet other FDA regulatory requirements, such as establishment registration and device listing.
The UDI system should be open to technological advancements. The UDI system should not require use of any particular technology, but should allow for technological evolution and advancement.
Requirements will be designed to integrate smoothly with other existing and planned FDA systems, such as registration and listing, postmarket surveillance, and adverse event reporting.
Requirements should be phased in over a period of some years. By implementing UDI system requirements in stages, all participants — FDA, industry, the health care community, and other government agencies — will have ample time to become familiar with and implement the rule’s requirements. This approach will also give FDA opportunity to identify unforeseen weaknesses or problems in our implementation of the UDI system and to make appropriate mid-course corrections.
The UDI system should make considerable provision for regulatory flexibility, including exceptions and alternatives when shown to be appropriate. For example, investigational devices are exempted from many regulatory requirements; it may be appropriate to exempt investigational devices from UDI requirements. Case-by-case exceptions / alternatives may also be appropriate, and a process to consider requests for exceptions / alternatives would be consistent with the statutory directive.
Safeguards should be provided to protect small businesses. FDA will monitor the effects of the proposed rule, and we will take action if we find that a significant number of small businesses will be harmed.
UDI data should be freely available to all. Free access to UDI data will encourage the integration of UDI data into existing procurement and inventory management systems, healthcare delivery support systems, electronic patient records, and will allow those systems to work together more effectively. With UDI data freely available, we expect many creative and innovative uses to be developed.