FDA Tempers Accuracy Standards For Hospital Glucose Meters In Final Guidance
The US agency finalized two closely watched guidance documents for blood glucose systems used in the hospital and at home. The guidance focusing on hospital point-of-care systems included a key revision of proposed accuracy standards from a 2014 draft guidance that had been broadly maligned as too tough.
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The agency finalized two parallel guidance documents in 2016 relating to hospital point-of-care and patient over-the-counter use of blood glucose meters. But it has now reissued the documents in draft form to make what an agency spokeswoman referred to as "mostly minor" changes.
FDA says it has become aware of large data sets that raise new questions about the level of accuracy that blood glucose meters can deliver in an intensive-care hospital setting using capillary blood samples. An advisory panel will be tasked March 30 with considering the issue and its impact on assessing risk-benefit of the devices in the hospital environment.
FDA hopes the clearance of Nova Biomedical’s Nova StatStrip blood glucose monitor for hospitalized patients will help alleviate fears that increased regulatory standards will restrict critically ill patients’ access to point-of-care glucose testing. But the clearance does not necessarily settle the agency’s long-term policy plans for hospital-use glucose meters.