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FDA Catches Heat For Plans To Raise Standards For Hospital Glucose Meters

An FDA draft guidance issued earlier this year on hospital glucose meters has attracted an unusual amount of attention, including criticism from clinicians, companies and others who worry it could cut off access to point-of-care glucose testing in patient cases where it is needed. The agency says it is taking appropriate measures to address a safety issue, and that some of the criticism is misdirected.

FDA’s draft guidance on hospital glucose meters circulated in January has made waves with manufacturers and clinicians, including many who believe the agency has gone too far in its pursuit of more accurate meters in hospitals by proposing standards that are virtually impossible to meet. What’s more, hospital lab managers say language in the draft guidance has set off activity by other authorities that could prevent access to glucose meters in hospitals for critically ill patients.

In addition to the response from direct stakeholders, the draft guidance has attracted high profile attention, including opposition from the U.S. Chamber of Commerce and criticism from U.S. senators.

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