Hospitals Urge FDA to Delay Final Guidance On Blood Glucose Monitoring Systems

The American Hospital Association (AHA) in a recent comment letter criticized a Food and Drug Administration (FDA) draft guidance on prescription point-of-care (POC) use blood glucose monitoring systems. The AHA said it was concerned the draft guidance would have serious unintended consequences for patients and hospitals, including placing patients at unnecessary risk. Nova Biomedical, a manufacturer of POC blood glucose systems, also warned the FDA about potential unintended consequences of specific areas of the guidance document but stopped short of calling for an enforcement delay. Nova Biomedical Corp. is based in Waltham, Mass. The FDA Jan. 6 issued two separate draft guidances, describing what manufacturers should include when they submit 510(k) premarket notifications for self-monitoring blood glucose test systems for POC use as well as over-the-counter (OTC) use. In April, comments were extended from their original due date until May 7. Nova Biomedical told the agency that issuing two separate draft guidances “will improve the safety and effectiveness of the devices used in POC settings.” The AHA, however, urged the FDA to delay issuing final guidance until it consults with stakeholders to consider alternatives “that do not have the unintended consequences of inappropriately limiting proper use of glucose meters in hospitals and in other health-care settings.” The hospital group wants the agency to convene a workshop with hospitals, device makers, and other interested parties before the FDA makes the guidance final. Historically, the FDA said it hasn’t recommended different types of information in 510(k)s for blood glucose meters used by medical professionals as compared to OTC self-monitoring devices intended for lay users. In recent years, however, concerns have been raised, including infection-control issues related to POC glucose meters, the agency said in the draft guidances. As a result, the FDA proposed different accuracy and study requirements for each environment that reflect the intended use of the devices. Regulation Level The AHA in its comments expressed concern that the guidance essentially deems hospital blood glucose testing an “off-label” use, which effectively nullifies the automatic waiver status from the Clinical Laboratory Improvement Amendments (CLIA) that OTC blood glucose meters currently in use have been granted in hospital settings. According to the AHA, under the CLIA law, tests, including meters, approved by the FDA for OTC “home use” are automatically categorized as waived tests, which are then subject to the lowest level of CLIA regulatory requirements. This waiver allows hospitals to use these meters for convenient, rapid, and real-time bedside testing. But if the FDA policy change deems hospital use as off-label, the AHA said, the meters would be subject to the highest level of regulation under CLIA as “high complexity” testing, which could be detrimental to patient care. This is because hospitals would have to abandon bedside testing in favor of central lab testing, which the hospital industry said would delay care for patients. The FDA in the draft said it expects that prescription-use blood glucose monitoring devices generally will be categorized upon clearance as “moderate complexity” and encouraged manufacturers to apply for a CLIA waiver determination if they were interested in being considered for a waiver. In addition, the hospitals noted that New York state regulators already have issued a letter to hospital labs citing the FDA draft and saying that the hospitals using glucose meters in populations for which the device wasn’t approved would be engaging in off-label use. Given the concerns, the AHA recommended that the FDA immediately issue a statement clarifying that its draft guidance “should not be used by state or federal regulatory agencies as a tool to enforce new restrictions and requirements on the use of blood glucose meters in hospitals or in other health care settings.” Clinical Trial Expansion Manufacturer Nova Biomedical, which produces the Nova StatStrip and StatStrip Xpress systems, said it supports the FDA’s intent to increase the number of subjects per specimen type to optimize the confidence level within a clinical study. However, the company said the requirement should be the same for all POC devices in professional health care settings, not just blood glucose test strip systems. Nova Biomedical also said it was “strongly concerned that the proposed guidance document provides an easy pathway for manufacturers to make claims for populations that are particularly vulnerable to potential interferences” based on the number of patients allowed from different sites of care. “The outcome of this proposed guidance document is that a new device would be cleared with an indication for use claim that includes MICU and SICU based upon a total of only 100 specimens,” Nova Biomedical told the FDA. “The unintended outcome of this new labeling claim would be that health-care facilities and inspectors may interpret this indication for use to mean the new device is cleared for use with critically ill patients within these settings. We do not believe this is FDA’s intent.” The company said the FDA “should clarify this point within the guidance document to ensure this Indication for Use would not lead health-care facilities and inspectors to interpret the device as safe and effective for use with critically ill patients.” Takeaway: Recent draft guidance issued by the Food and Drug Administration on prescription point-of-care use blood glucose monitoring systems would have serious unintended consequences for patients and hospitals, believes the American Hospital Association.