The U.S. Food and Drug Administration (FDA or the agency) issued the final Unique Device Identifier (UDI) rule on Tuesday 24 September 2013, following up on the draft rule previously circulated by the agency on 3 July 2012.
Overview of the UDI requirements
With limited exceptions, the rule requires that medical devices are labeled with a UDI in both a plain text format and in a format that uses automatic identification and data capture (AIDC) technology, such as a bar code or radiofrequency ID. The UDI must be placed on the medical device labels and packaging and the UDI must include two parts: both a device identifier and a production identifier. The device identifier corresponds to the version or model of the device, and the production identifier identifies the specific device through means such as the serial number, lot, batch, expiration date, or date of manufacture. For a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device, the production identifier can include the distinct identification code required for these devices under 21 C.F.R. §1271.290(c).
Labelers must enter device UDI information into the FDA’s new Global Unique Device Identification Database (GUDID, pronounced ‘good ID’) prior to distribution of the product. Information can be entered into the GUDID manually or using coded XML and HL7 formats. Organizations have developed data pools to help companies with large volumes of devices register their products with the FDA. The GUDID will only require companies to provide information on the device identifier and the general type of production identifier that is included on the labeling, not the actual production identifier for every device manufactured. Along with the final rule, the FDA issued a draft guidance, Global Unique Device Identification Database (GUDID), that provides further information on how to enter information into the GUDID.
Changes from the proposed rule
The FDA appears to have carefully considered a number of concerns raised by the industry, and the final rule includes some notable differences from the proposed rule, in response to these concerns. Of particular note:
- Direct-marking requirement. In an important win for the industry, manufacturers of implants and stand-alone software products will no longer be required to directly mark implants. Direct marking is only required for products that are reprocessed and intended for more than one use.
- Kits and combination products. For convenience kits and combination products, the individual components do not require labeling with a UDI, as was suggested in the proposed rule. Rather, only the kit or the combination product itself will be required to bear a UDI.
- Date format. To allow standardization with the requirements of the European Union and other nations, dates provided on device labels are to be presented in the following format: YYYY-MM-DD.
- Stand-alone software. The final rule created a separate section to address stand-alone software. While stand-alone software is no longer subject to direct-marking requirements, the package of the software must include a UDI and the software start-up screen or menu command must also provide the UDI information.
- Clarification of the term ‘labeler.’ The device labeler is the entity that is responsible for placing the UDI on a product and listing the product in the GUDID. The definition of ‘labeler’ has been refined as follows: A person who causes a label to be applied to a device with the intent that the device will be commercially distributed (not placed into interstate commerce as suggested in the proposed rule) or replaced or modified the label with the intent that the device will be commercially distributed. The FDA clarified during its recent UDI conference on September 26-27 that a labeler is defined as an entity that has the intent to put the product into distribution, not necessarily that this distribution has already occurred. If a manufacturer is just adding ‘distributed by…’ to the label, then that entity is not a labeler subject to these requirements.
- When is a new UDI necessary? Products that are relabeled will require a new UDI. For changes to a device, a new UDI is necessary only when the change to the device results in a new version or model of the product. This provides greater flexibility and discretion for companies than the proposed rule.
- Devices manufactured prior to the compliance deadlines. For final, finished, already-labeled devices that have been manufactured prior to the compliance date and either held in inventory by the manufacturer or consigned to a hospital or other potential purchaser, there is an additional three-year grace period beyond the compliance date for that type of device.
- MR compatibility information. Under the final rule, GUDID users must indicate whether patients may be safely exposed to MR while using the device or while it is implanted. The FDA emphasizes that the final rule does not require MR-compatibility testing, only the submission of information that a labeler already possesses. The GUDID will provide a means to indicate that MR compatibility has not been evaluated.
Exceptions to UDI requirements. The final rule retains the exceptions to the UDI requirement included in the proposed rule and includes new exceptions. Among the categorical exemptions, the following types of products are exempted from UDI requirements:
- class I devices which are exempt from 510(k) notice and GMP requirements;
- shipping containers;
- custom devices;
- investigational devices.
Companies should document that a device qualifies for an exception to the UDI requirements in the product’s design history file. Companies may also request an exception to the UDI requirements. Any decisions on exceptions to UDI requirements will be made publicly available.
Effective and compliance deadlines
For purposes of compliance with the rule, implementation of the UDI requirements will be based on the publication date of the final rule on 24 September 2013.
Effective dates - Exception requests and provisions related to accreditation of UDI providers (all UDIs will be issued by one of three accredited agencies) will be effective in 30 days. The remainder of the rule becomes effective in 90 days.
Regarding the application of UDIs to product labels and registration in GUDID, the following compliance dates apply to medical device labelers:
Year one. Class III and devices licensed under Public Health Service (PHS) Act
- Manufacturers of class III devices may submit a request for a one year extension where the extension is in the best interest of the public health. The agency stated during the recent UDI that it does not intend to grant compliance extensions for any other classes of devices.
- Year two. Class II/I implants and life-supporting/sustaining devices. The FDA has published a list of devices that fall into this category. During the recent UDI conference, the FDA noted that if a manufacturer believes its device falls into this category but it is not included in this list, it is up to the manufacturer to decide when to comply. The FDA noted that it plans to abide by information included in its published list.
- Year three. Remainder of class II devices
- Year five. Class I devices; unclassified or not classified devices
For those devices that are subject to direct-marking requirements, manufacturers are subject to the compliance deadlines based on the classification of the device, plus an additional two years to comply with the direct-marking requirement. Accordingly, if a class III device is subject to direct-marking requirements, it must comply in year three, whereas if a class I device is subject to direct-marking requirements, it must comply with this aspect in year seven.
The GUDID is currently available for those products which are impacted in year one, though the search feature is not yet active, and the coded HL7 and XML data entry options will not be available for another month. Companies who are subject to compliance with the UDI requirements in year one should obtain user login information and begin to become familiar with the database requirements. Additionally, companies should continue their development of SOPs regarding integration of UDI information into product labeling.
As with any broadly applicable novel system, there are expected to be some hiccups as implementation is underway. While there is no further opportunity available to comment on the final rule, the agency is accepting comments on the draft GUDID guidance document through 22 November 2013. Additionally, persons are encouraged to contact the FDA for any questions through their website help desk tool at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm368904.htm