USA – 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 systemsRegulatory Focus 29 November 2018)…