FDA letter to HbA1c test makers
This article was originally published in The Gray Sheet
Executive Summary
FDA is encouraging makers of hemoglobin A1c (HbA1c) assays to meet with the agency if they wish to pursue new diagnostic claims for their blood tests based on new data and updated guidance from the American Diabetes Association. ADA recently updated its recommendations for diabetes treatment standards to state that HbA1c test values of greater than or equal to 6.5% may be used to diagnose diabetes. However, no HbA1c test has yet been cleared by FDA with a diagnosis claim. The tests are cleared to monitor long-term glucose control in diabetes patients