In newly released guidance documents FDA regulators for the 1st time laid out separate 510(k) application recommendations for blood glucose meters intended for over-the-counter patient use and those designed for professional healthcare settings.
The distinction allows the FDA to place greater emphasis on infection control concerns raised about in-clinic point-of-care devices, which are more likely to be used on multiple patients. The guidance also aims to address concerns that over-the-counter devices aren’t sufficiently tested for clinic settings, where patients are sicker and inaccurate testing may pose a greater risk.
Patients-use systems, on the other hand, are likely to undergo different storage and handling conditions, suggesting that they be developed to be more "robust and reliable" than their clinical counterparts, the FDA said in the guidance covering OTC systems.
"Previously, most blood glucose monitoring devices, even those intended to be used by healthcare professionals, were submitted to FDA with claims for OTC use. Thus, they were evaluated for self-use by diabetics, and the specific issues that occur in the professional healthcare setting were never addressed," according to the FDA proposal on point-of-care devices. "Use of glucose monitoring devices in professional healthcare settings when they were cleared for lay use puts patients at increased risk. The performance of the devices was not evaluated in the intended use population, and the scientific and clinical issues may not have been adequately addressed for these uses."
The agency recommended distinct guidelines to separate prescription glucose meters from patient-use systems, no longer providing clinic devices with automatic waivers from Clinical Laboratory Improvement Amendments requirements.
Since 1997 home-use tests have been automatically waived from CLIA because they were deemed "so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly," according to FDA regulations. OTC systems will remain under CLIA waiver categorization, but prescription systems will need to apply for a waiver.
"If you intend to pursue CLIA waiver for your prescription-use BGMS device, you should consider slightly increasing the study size and performing studies that are designed to support 510(k) clearance as well as CLIA waiver," the FDA said.