Medical devices; exemption from premarket notification; class II devices; triiodothyronine test system. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for the triiodothyronine test system with certain limitations. This rule will exempt from premarket notification the triiodothyronine test system intended for measuring the hormone triiodothyronine in serum and plasma. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Action of 1997 (FDAMA).