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Regulatory Focus™ > News Articles > 2020 > 9 > FDA finalizes blood glucose monitor guidances

FDA finalizes blood glucose monitor guidances

Posted 28 September 2020 | By Michael Mezher 

FDA finalizes blood glucose monitor guidances

The US Food and Drug Administration (FDA) on Monday finalized guidance providing recommendations for device makers looking to submit 510(k)s for prescription point-of-care and over-the-counter blood glucose monitoring systems (BGMSs), two years after the agency went back to the drawing board to address concerns about its previous guidance.
FDA first issued final guidance on point-of-care and over-the-counter BGMSs in October 2016. In November 2018, in response to industry feedback on the final guidances, FDA issued two draft guidances proposing changes to the documents that would give device makers greater flexibility when developing and testing their products. (RELATED: FDA reissues two draft guidances on blood glucose monitoring test systems, Regulatory Focus 29 November 2018).
FDA explains that it has developed specific recommendations for BGMSs intended for use in professional healthcare settings to reflect the needs of patients in professional healthcare settings and to address a different set of risks than those encountered by patients using over-the-counter devices for self-monitoring.
“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,” FDA writes. Some of those risks include the potential for transmitting bloodborne pathogens between patients and the devices’ use for patients who are more likely to be “acutely ill and medically fragile and are more likely to present physiological and pathological factors that could interfere with glucose measurements relative to lay-users.”
FDA also explains that it expects point-of-care BGMSs will be categorized as moderate complexity under the Clinical Laboratory Improvement Amendments (CLIA) upon clearance, but says it “intends, through the studies described in this guidance, to facilitate CLIA waiver for these devices” and recommends that device makers submit a dual 510(k)/CLIA waiver submission or an associated application for CLIA waiver.
In its guidance for self-monitoring blood glucose test systems (SMBGs), FDA says it believes that providing specific guidance for devices meant for lay users will lead to greater safety and efficacy. FDA points out that lay users comprise a wide range of patients of various ages, dexterity, vision and training and that the devices and test strips “are more likely to experience varied storage and handling conditions compared to devices used in professional settings.”
Both guidances make recommendations for reducing the risk of bloodborne pathogen transmission, device description and performance evaluation to support 510(k) submission, as well as recommendations for test strips, software and labeling for the respective devices.
Similarly, the two guidances largely mirror their respective draft versions and include recommendations for device makers to consider features that will increase user accessibility, such as features for users with visual impairments, and make a technical correction to the listed recommended hemoglobin testing concentration.
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use
Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use

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