FDA releases draft guidance on blood glucose monitoring systems
The Food and Drug Administration has issued draft guidance on blood glucose monitoring systems for prescription point-of-care use by healthcare professionals.
The FDA’s proposed guidance specifically covers blood glucose monitoring systems (BGMSs) used by healthcare professionals in a variety of clinical settings, but is not meant to address self-monitoring blood glucose test systems (SMBGs) for over-the-counter home use.
“Historically, the FDA has not recommended different types of information in premarket submissions for BGMSs intended to be used by healthcare professionals as compared to over-the-counter SMBGs intended for home use by lay-users,” states the document.
However, at the same time, the regulatory agency contends in the draft guidance that “it has become increasingly clear that these different use settings comprise distinct intended use populations with unique characteristics that can impact device design specifications, and that manufacturers should take these unique characteristics into account when designing their devices.”
The agency specifically calls out concerns that have been raised by the Centers for Disease Control and Prevention related to infection control issues involving blood glucose meters and lancing devices.
“Blood glucose meters can transmit bloodborne pathogens if these devices are contaminated with blood specimens and are shared between users without effective cleaning, disinfecting and appropriate infection control measures,” states the FDA document. “Because BGMSs used in professional healthcare settings are more likely to be used on multiple patients, this type of use requires certain design features and the capacity for cleaning and disinfection to prevent the spread of bloodborne pathogens.”
To ensure that these devices are better designed to meet the needs of healthcare professionals, the FDA’s draft guidance describes studies and information that the agency recommends be used when submitting premarket notifications for BGMSs for prescription point-of-care use.
“When finalized, this guidance document is intended to guide manufacturers in conducting appropriate performance studies and preparing 510(k) submissions for these device types, and will replace the final guidance entitled ‘Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use’ issued on October 11, 2016,” according to the FDA.