FDA issues draft guidance on blood glucose monitors
The updated recommendations apply to industry and, when finalized, will update previous guidance issued in 2016.
The FDA has issued draft guidance to help ensure the accuracy, reliability, and safety of blood glucose monitoring test systems for prescription point-of-care use and self-monitoring blood glucose test systems for over-the-counter use, the agency announced on Nov. 29.
The FDA is seeking comments and suggestions on the revised guidance, which provides recommendations to industry about the types of information that should be included in premarket submissions for blood glucose monitors. Revisions to the guidance were based on stakeholder feedback, which requested clarification on design considerations and recommended standards.
When finalized, the new guidance will update two documents issued in 2016.