HHS FDA Classifies Orthopedic Infection Diagnostic Device as Class II Medical Device
May 20, 2026
May 20, 2026
WASHINGTON, May 20 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued a final rule on May 12, 2026, classifying a category of diagnostic medical devices designed to detect and identify microorganism nucleic acids and antimicrobial resistance markers in patients with suspected orthopedic infections. Published in the Federal Register, the rule places the device type into Class II with special controls, rather than the more restrictive Class III category . . .