Blood Glucose Manufacturers Push for Regulation Changes

The 510(k) clearance process for blood glucose meters should be updated to include a standardized list of interferences for which manufacturers must test. “There is a wide variation in the number of interferences tested by manufacturers, ranging from five to more than 100,” Roche Diagnostics says in a comment on the FDA’s efforts to update its guidance on glucose meter standards. “Consumers should have confidence that whatever product they choose has been rigorously tested and proven effective.”
Devices & Diagnostics Letter