The Food and Drug Administration has issued draft guidance on blood glucose monitoring systems for prescription point-of-care use by healthcare professionals.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.
