The Food and Drug Administration today issued draft guidance describing the premarket studies that manufacturers should conduct for blood glucose monitoring systems intended for use in professional health care settings. Based on feedback from the clinical community, the guidance recommends that manufacturers ensure the studies are designed to support a Clinical Laboratory Improvement Amendments waiver for the device. A CLIA waiver allows hospitals to use the device at the point of care. Historically, FDA has not distinguished between requirements for blood glucose monitoring systems used in hospitals and other health care settings and over-the-counter meters used for self-monitoring, which are automatically waived under CLIA. FDA will accept comments on the draft guidance for 90 days after its publication in the Federal Register. 
 

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