The FDA received 21 sets of comments on the draft guidance from manufacturers such as Abbott, GE Healthcare, Covidien, Johnson& Johnson, Merck, Cook Group, the Orthopedic Surgical Manufacturers Association (OSMA), the Advanced Medical Technology Association (AdvaMed) and the standards group GS1. The manufacturers all identified enhancements the FDA could make to the draft guidance that they said would help improve the user efficiency of unique device identifiers, which are required under a September final rule the agency issued along with the guidance. For example, J&J took issue with one of the key data elements for the UDI database, the Global Medical Device Nomenclature (GMDN), which are internationally recognized terms to describe different devices. According to Johnson & Johnson, terminology can change or become obsolete, so the FDA should specify the time frames required for updating the GMDN information within the database.
Among more specific concerns, AdvaMed suggested the FDA take a “living document” approach to implementing UDIs, including the GUDID, as the implementation plan is so complex. “As both FDA and industry gain experience in UDI implementation the GUDID Guidance should be updated and improved as needed,” AdvaMed said.
According to the FDA, the GUDID is a publicly searchable database administered by the FDA that will serve as a reference catalog for every device with an identifier. Under the UDI final rule, the labeler of each device labeled with a unique device identifier (UDI) must submit information concerning that device to the GUDID, unless subject to an exception or alternative.
A final rule that was published in the Federal Register Sept. 24 (78 Fed. Reg. 58,785) will require medical devices to carry a UDI (7 MELR 605, 10/2/13). The agency also issued a concurrent draft guidance for manufacturers outlining how to submit information to the database. Comments on the draft guidance were due Nov. 25. Implementation of the UDI system will span several years, starting in 2014. The draft guidance was designed to help labelers prepare to submit information to the GUDID by describing key GUDID concepts such as accounts, user roles, the device identifier record life cycle, package configurations, and the GUDID data attributes and descriptions, the FDA said.
A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date, the FDA said. According to the FDA, a UDI system has the potential to improve the quality of information in medical device adverse events reports.
With a device’s UDI, physicians will be able to use the global database to positively identify the device and obtain important descriptive information, preventing confusion with any similar device that might lead to device misuse. The FDA said the database will serve as a reference catalog for every device with an identifier, but no patient data will be included.
According to the agency, the GUDID provides two options for submitting device identification information:
• a Web interface, which enables structured input of device information as one device identifier record at a time; and
• an HL7 SPL submission, which enables submission of device information as XML files.
Both submission options require a GUDID account. GUDID device information submission will initially be open only to labelers of currently marketed class III medical devices and devices licensed under the Public Health Service Act (PHS Act), the FDA said. The agency has said it plans to offer a search capacity for public access to the database, but that function is disabled until there are more submissions.
A key aspect of the GUDID is that a device’s identification information may be updated and edited. The agency instituted a seven-day grace period, after which only certain attributes of the device can be edited. According to the FDA, a published device identifier (DI) record is available for search and retrieval by the public. During the seven-day grace period, all associated data attributes can be edited by a databse user, so long as the edits don’t trigger a new DI.
The guidance said that the labeler can add new entries but cannot delete entries after the grace period. According to AdvaMed’s comments, “this is misleading because the labeler can effectively delete the Package DI by entering a ‘Package Discontinue Date.’” According to AdvaMed, changes to clinical size attributes don’t trigger a new ”Primary DI,” so the details of those entries should be able to be edited or deleted after the grace period.
“A company may change the measurement stated on the label, without affecting the actual size of the device, for example changing from U.S. to metric measurements. Likewise, whether a device is exempt from premarket submission or not, it does not change the product or its labeling. A device’s regulatory status can change from exempt to 510(k) [premarket notification] and vice versa. A change to this data element does not trigger a new Primary DI and therefore should be editable after the grace period,” AdvaMed wrote. AdvaMed recommended that data elements should, as a rule, be open to edits “to allow labelers to maintain accurate alignment between the GUDID and the product label. These points should be clarified in the next version of this guidance,” the group said.
The Cook Group, a Bloomington, Ind.-based device company, told the FDA that the database should allow users to save edits in a draft form without affecting the already-published record. Cook also said the agency should set a “publish-by” feature, so users making edits can choose when the changes are implemented. For example, in the case of a merger or acquisition, “many thousands of records” may need to be updated, Cook said. By initiating those changes well in advance, labelers would be able to plan for the changes and ensure the GUDID is accurate.
According to the draft guidance, the database requires companies to obtain a Dun & Bradstreet Number (DUNS or D-U-N-S) as well as a Global Medical Device Nomenclature Preferred Term Code. Each GUDID account is identified by a DUNS Number; this DUNS number represents the labeler’s view of the highest corporate level in the labeler organization; it may be the headquarters DUNS number, or the parent DUNS number for the labelers included in the GUDID account, the FDA said. The guidance said that the labeler name and address retrieved from the D&B database should match the name and address on the device (one DUNS number equals one labeler).
However, J&J told the FDA that “there are many instances where the same product (with the same catalog code) is manufactured under two different legal manufacturers (labelers) and manufacturing sites or where product is manufactured at one site and is labeled at two different labelers. We understand the Agency’s desire for a 1 to 1 relationship, but this requirement implies that the products manufactured under these scenarios would require a separate UDI (DI) and this would significantly impact our current processes.”
In addition, AdvaMed recommended that the FDA should provide flexibility in identifying the company name and address associated with the DUNS number in the labeler’s GUDID account profile. AdvaMed said the FDA should allow the DUNS number to be associated with the manufacturer’s legal name and address, or the manufacturer’s name or address printed on the label.
J&J, based in New Brunswick, N.J., also told the FDA that “while we support the Agency’s use of GMDN codes as a data element for GUDID, we are concerned with the utilization of GMDN given the current practices of short notification periods for replacement GMDNs and terminology and the obsolescence of terms.”
Because terminology can change or become obsolete, J&J said, it “appreciates that this data element can be edited after Grace period; however, we would like FDA to specify the timeframes required for updating this information within GUDID.”
In addition, the company said the draft guidance seems to imply that the device descriptor is based on the GMDN descriptor. “This does not reflect business practices and we are concerned that if this is expected there will be a potential label revision increase when terminology changes,” J&J said. “We are also concerned with this example as there are instances where GMDN code and terminology is the best match to our products, but is not identical to it, and as a result could create confusion for our customers.”
REFERENCE: Bloomberg BNA; Thursday, December 12, 2013; Nathaniel Weixel