Recent research has discovered that even though a blood sugar monitor meets the U.S. Food and Drug Administration’s criteria for accuracy to gain device authorization, the meter or test strips found in the meter may not perform as well as expected in real life. And, those errors can have life-threatening implications possibly. Current standards, that have been approved in 2003, require that measurements be within 20 percent-either over or under-or a comparable laboratory test if the blood sugar level happens to be above 75 milligrams per deciliter (mg/dL).
A draft guidance document premiered in January by the FDA asking manufacturers to meet up with the 15 percent goal for 95 percent of bloodstream sugar readings, apart from very low bloodstream glucose readings. The guidance record tells manufacturers the actual FDA expects of these to gain approval. A draft of the assistance document will be available for several months to permit for public comment before the final record is produced. However, the accuracy goal identifies quantities achieved to device authorization prior.
Some of that feedback to the FDA may be coming from a new campaign, called Strip Safely, started by Bennet Dunlap, a paternalfather with two teenagers with type 1 diabetes. Dunlap said he wants to make certain that the FDA uses its capacity to recall faulty diabetes equipment in a quite similar way that it polices other products.
Dr. David Simmons is the main medical official of Bayer HealthCare’s Diabetes Care, in Tarrytown, N.Y. Another manufacturer, Abbott Diabetes Care in …