First Glucose Meter Cleared For Hospital ICUs As FDA Continues Work On Guidance-thegraysheet: The clearance does not necessarily resolve the broader debate about regulatory standards for hospital glucose meters going forward. Lias stressed that the January document is draft guidance and that it did not play a role in FDA’s review of Nova’s submission. “It was not a factor at all in this clearance,” the FDA official told “The Gray Sheet.” An assessment based on the standards described in the draft guidance “was not even done because it is draft guidance,” she said. “It is not something that is applied or used.”
