With some notable exceptions, most public comments received by FDA on its proposal to require unique device identifiers (UDI) support both the essential thrust and the details of the proposal. Individual companies, however, sought various exceptions from it.
In its comments, the Consumer Healthcare Products Association (CHPA) said it agrees with that part of the proposal that would exempt nonprescription Class 1 from UDI labeling and data reporting requirements.
“The imposition of these requirements to Class 1 and nonprescription devices at retail would, rather than advancing FDA’s goals, add unfocused and unnecessary complexity to a market-based system where nonprescription devices include universal product codes for each stock-keeping unit,” the CHPA letter said. “Further, the law under which this requirement would be implemented envisions its application to devices that are implantable, life-saving, and life-sustaining. Neither Class 1 nor nonprescription drugs at retail would fall within that scope.”
Opposition to all exceptions was voiced in a comment by Suresh Nirody. “There should be no general categories or classifications of devices excluded by rule,” Nirody wrote. “Given the importance of the public health objectives that will be facilitated by the existence and use of UDI, the number of items or categories exempted from the UDI requirement should be minimized to the fullest extent possible.” The letter praises the UDI proposal as “an important milestone [that] is vital to the achievement of the public health objectives enumerated in the proposed rule’s executive summary.”
Merck’s Consumer Care said it supports the proposed exemption from the UDI requirement for OTC Class 1 and 2 devices and devices that pose very low risk. The company asked for confirmation that Internet purchase of Class 1 and 2 OTC devices also qualifies for an exemption. Merck said it does not support a provision that would allow voluntary labeling of a device with a UDI. The reason? It may be confusing for retailers and healthcare agencies if some manufacturers include a UDI and others do not.
In its comments, the American Hospital Association said a fully implemented UDI system will enable a medical device tracking system for hospitals to use in patient care, response to safety recalls, and supply chain management. Thus, it urged FDA to accelerate the time of the complete rollout of a UDI system from the proposed seven years after adoption of a final rule to three years. “Safety advocates and patients have waited a long time for the UDI,” the associated wrote, “and we see no compelling reason to wait an additional seven years.”
In its comments, Kaiser Permanente called on FDA to:
- Prioritize patient safety.
- Adopt a single UDI standard.
- Support cross-references in the UDI database.
- Provide database governance, change control, and maintenance.
- Align and coordinate UDI with HIPAA and other federal and state requirements and programs.
- Enable comparative effectiveness research.
Medline, which says it manufactures more than 17,000 unique medical convenience kits, some of which contain more than 50 medical devices, asked FDA to proceed cautiously in seeking to apply the UDI system to such kits. “FDA should separately weigh the costs/benefits of the UDI system for medical convenience kits and should ensure that any UDI requirements that apply to kits provide real value to patients and providers without increasing the cost or complexity of this valuable service.
“In general, we believe that the proposed rule is unclear and incomplete as it relates to medical convenience kits, leaving many important issues unresolved,” Medline wrote. “We believe FDA should hold further public consultation on this topic prior to completion of the final rule. FDA should hold a public workshop and provide an additional opportunity to submit comments once a more complete version of the medical convenience kit section has been developed.”
Novo Nordisk asked FDA to except certain Class 2 single-use devices such as certain types of needles from the requirement to bear a UDI on the individual unit-of-use of the device (each needle). The company proposed that such devices bear a UDI on the next, higher level of packaging.
The Health IT Standards Committee said that the proposal will have many benefits for health and healthcare and that the proposed UDI database is particularly notable as a positive step in the right direction for healthcare and supporting processes. It said that proposed exemptions from UDI requirements for retail devices are troublesome and problematic. Many devices that are proposed to be excluded are integral to healthcare and can be paid for by Centers for Medicare and Medicaid Services programs, it added.
B. Braun commented that the assumption that all people and functions in a hospital or other clinical setting will have and use the required equipment to scan product data, real time, to prevent using outdated or recalled product before it reaches the patient will be extremely difficult and costly to implement and maintain. Systems required to manage data will be complicated and prone to errors, the company warned. And scanning disposable devices every time one is needed is unlikely and highly taxing on healthcare providers. “With limited resources, scanning of products may not be considered a necessity or provide any value to healthcare.”
The Medical Imaging and Technology Alliance said it expects “substantial increases in device manufacturer costs associated with the initial implementation of this regulation and continued compliance with its requirements.” The group said there will be increases associated with implementation costs, transactional costs, follow-up costs, and maintenance costs. It also urged FDA to work with other regulatory bodies globally to achieve a harmonized regulation.
The mHealth Regulatory Coalition said that while it recognizes the significant value that the UDI system may have for public health, FDA should consider the impact of the proposed rule on the mobile health industry. The coalition said it supports the rule’s proposed retail exception but wants clarification as it relates to mHealth technologies. It also supports the proposed exception for Class 1 devices that are exempt from good manufacturing practice requirements.
In contrast to generally favorable comments by individual companies, the Advanced Medical Technology Association (AdvaMed) recommended changes it said would make the system more practical and useful. While it expressed support for FDA’s main goal in the proposal, AdvaMed said implementation of a UDI system “is a costly proposition, one that should be carefully considered such that it is implemented correctly the first time, and that its ongoing use is practical, economical, and of value to patients, healthcare providers, industry, and the FDA.”
Among significant changes to the proposed rule suggested by AdvaMed were:
- Manufacturers of Class 3 devices should be given two years after the final UDI rule is issued to comply with the rule’s labeling requirements, instead of one year.
- FDA should develop a specific list of devices exempt from UDI direct marking requirements, such as absorbable sutures or stents, because such devices can’t be directly marked.
- FDA should clarify that devices manufactured before the final UDI rule’s effective date but held in inventory are not subject to the rule.
“AdvaMed has long supported establishment of a UDI system,” association president Stephen Ubl said, “and believes that if appropriately implemented, such a system holds the promise of more accurate and consistent post-market surveillance.” He offers the following caveates: “[...] it is important to understand that any benefit from a UDI system depends on device users consistently and effectively utilizing the system for tracking recalls, adverse event reporting, and within electronic health records. FDA’s proposed rule is a good first step and we are committed to working with FDA and other stakeholders to develop an effective UDI system that takes into account the diversity of medical devices and provides information useful to understanding their post-market performance.”