UDI and You: What FDA’s Proposed Rule Means for IVD Manufacturers
The diversity of the IVD industry will make blanket compliance challenging.
On July 10, 2012, FDA published a proposed rule that requires unique device identifiers (UDIs) for medical devices and described the labeling requirements that will now be included in 21 CFR Part 801 (Labeling).1 This proposed rule was published in response to a requirement in the Food and Drug Administration Amendments Act (FDAAA) 2007 directing FDA to promulgate regulations establishing a UDI system for medical devices.2 Section 226 of the FDAAA of 2007, P.L. 110-85, amended the Federal Food, Drug, and Cosmetic Act to add new section 519(f). The requirement reads:
“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 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.”
UDIs are described as “a unique numeric or alphanumeric code that contains a specific device identifier and is specific [to the] device for which it was developed. The UDI includes current production information for a specific device, such as the lot or batch number, the serial number, and/or expiration date.”3 In vitro diagnostic (IVD) devices are subject to this new rule.
The proposed rule from July 10, 2012, was amended on November 19, 2012, to modify the timeframe for implementation of requirements as they apply to devices that are implantable, life-saving (life-supporting), or life sustaining.4 Following publication of the final rule, manufacturers of Class III devices will have one year to meet all of the UDI requirements. Manufacturers of Class II devices will have three years to meet requirements and manufacturers of Class I devices will have a five-year window, with the exception of those making devices subject to direct part marking, label requirements and database requirements, who will have to meet all UDI requirements of the final rule one year after its publication. This new rule applies only to devices that manufacturers are preparing for market and currently are not distributing, not to devices that are already on the market.
In the Beginning
UDIs first were used in 2004, when FDA issued a regulation that required bar codes on pharmaceutical labels. Following promulgation of UDI regulations for pharmaceutical labels, subsequent public discussions turned to whether the Center for Devices and Radiological Health (CDRH) should develop a system for including UDI on labeling for medical devices.
At its annual meeting in April 2005, the Food and Drug Law Institute led a discussion on UDI and gathered feedback from representatives of various organizations regarding the use of a voluntary, uniform system of unique identification of medical device equipment.5 On October 25, 2006, FDA held a public meeting on unique device identification. At that meeting, then director of CDRH Daniel Shultz, MD, stated that “a UDI system is a major part of CDRH’s postmarket strategy and [that] FDA is committed to vigorously pursuing realization of the system, now and in the future, with input from government, industry, and global partners.”6
UDIs for medical devices, including IVDs, will probably be most useful in the postmarket cycle, given that, until recently, FDA did not have regulations mandating that 510(k) owners inform the agency whenever there is a purchase, sale, or transfer of ownership of a 510(k). Therefore, if there is a report of product failure, it would be difficult to find the current owner of the device and trace all the affected devices.
On August 2, 2012, CDRH issued a letter to all medical device establishments advising them of changes to the requirements for registration and listing of medical devices that would take effect on October 1, 2012. FDA also issued a new document, “Frequently Asked Questions about the New Device Registration and Listing Requirements,” that described the changes made and how manufacturers should update their registration and listing information.7
Currently, many IVD manufacturers use the Clinical Laboratory Improvement Act (CLIA) categorization process to notify the agency when there is a new distributor or transfer of ownership and the device is to be marketed under a new name. The new device is then listed in the FDA CLIA database.
What Does this New Rule Mean for IVD Manufacturers?
All IVD manufacturers now will have to submit information on their devices to the FDA Global Unique Device Identification Database (GUDID). The proposed rule published on July 10, 2012, states that FDA would establish a public database containing information about devices labeled with a UDI.8 Device manufacturers have to create their own UDI code in alignment with ISO 15459. To help manufacturers with this process, FDA stated that it will accredit issuing agencies to provide UDI codes to device manufacturers. Two agencies that are currently very active in developing standards for devices—GS1 and Health Industry Business Communications Council (HIBCC)—may be accredited as issuing agencies under FDA’s UDI system. FDA also stated that manufacturers who subscribe to other data systems and have third parties managing their UDI data may have those third parties submit data on their behalf to the FDA database.9
The UDI consists of the Device Identifier (DI) and Production Identifier (PI). The DI identifies a specific manufacturer’s version or model of a device; it is similar to an NDC number or UPC code. The PI consists of a lot number and expiration date, and would be part of the UDI code. The serial number or any other device-identifying information would become part of the PI. However, Class I medical devices are not required to have their PI embedded in the UDI. A list of devices associated with the UDI regulation can be found on the FDA website.3 The site also includes specific information for combination products and kits, i.e., specimen collection kits.
The UDI code is applied to all levels of packaging. If the device is intended for use by patients, then the UDI code is placed on all components of the device. The rule provides an exception for particular device types and for alternative labeling. Consequently, if the manufacturer wants to put the UDI somewhere other than on the label of the device, he or she should contact FDA to determine if that specific device would meet these exemptions. The UDI must be readable by end users and encoded in some form of automatic identification and data capture (AIDCT) technology, linear or 2-D bar code, or radio-frequency identification (RFID) system. The regulation does not identify a specific technology.
Additionally, expiration dates on device labels now will have to follow a specific format. Dates on medical device labels must be formatted as required by §801.18 of the proposed rule. The month should be presented in a three-letter format. For example, January would be JAN. There would always be a day, so a number from 1 to 31, followed by a four-digit year (JAN 1, 2103).
IVD manufacturers may have some hurdles to clear, given the diversity of the industry, which encompasses reagents, hardware, accessories, and so forth. However, the implementation timelines in the proposed rule should provide IVD manufacturers with enough time to familiarize themselves with the new database system and include unique identifiers on product labeling. FDA also stated that it would provide guidance documents to assist industry and FDA staff in implementing the new regulation.
According to presenters at FDA’s Public Meeting on Unique Device Identification, which was held on October 25, 2006, medical device UDI has the potential to yield several benefits, including improvements in public health and patient safety. The following were among the benefits cited at the meeting:
• better identification of devices in cases of adverse events;
• more rapid and accurate recalls;
• enhanced capabilities for postmarket surveillance;
• reduction in medical errors;
• easier identification of patient incompatibility with devices or potential allergic reactions;
• improved inventory control;
• improved reimbursement procedures;
• reduction in counterfeiting;
• streamlined tracking of recalled devices, which now is often done manually by healthcare providers in the field.
Potential hurdles cited at the meeting included difficulties related to accurately entering data in a newly developed centralized database and the cost.
FDA contracted the Eastern Research Group to provide a summary of costs for implementing a UDI system. Detailed data for this cost analysis is presented in the proposed rule, with references.1 The largest components of one-time costs, according to the analysis, would include integration of UDI into existing information systems, employee training, and the purchase and installation of equipment needed to print and verify UDIs on labels. The largest annual cost components include labor, software maintenance, and training needed to maintain the UDI information system.
Because UDIs also must conform to international standards, FDA will present a draft guidance document on UDIs to the International Medical Device Regulators Forum (IMDRF) by November 30, 2013. The document is intended to update the September 2011 Global Harmonization Task Force (GHTF) document, “Unique Device Identification System for Medical Devices.” The global medical device nomenclature (GMDN), which is recognized by regulators worldwide, also would be submitted as part of FDA’s global harmonization efforts.
1. Unique Device Identification System; Proposed Rule, July 2012;www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnaly….
2. The Food and Drug Administration Amendments Act (FDAAA) 2007; www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm.
3. Unique Device Identification (UDI); www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdent….
4. Proposed Rule; Amendment, Federal Register 77, November 19, 2012; www.federalregister.gov/articles/2012/11/19/2012-28015/unique-device-ide….
5. Report on Meeting to Discuss Unique Device Identification – April 14-15, 2005;www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdent….
6. FDA Public Meeting on Unique Device Identification, October 25, 2006;www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdent….
7. Frequently Asked Questions about the New Device Registration and Listing Requirements, October, 2012;www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDe….
8. Proposed Rule Details; www.regulations.gov/#!documentDetail;D=FDA-2011-N-0090-0001.
9. FDA’s Unique Device Identification (UDI) System; www.fda.gov/downloads/Training/CDRHLearn/UCM311634.pdf.
Freddie M. Poole, MS, MT, is head of FMPoole & Associates Consulting. She recently retired from FDA/CDRH after 28 years. Prior to that, she spent 15 years as a medical technologist. Poole has served on FDA workgroups, CLSI committees, and a WHO advisory panel.