Zdrowie i gospodarka · 11/07/2000

Medical Devices; Exemptions From Premarket Notification; Class II Devices: Triiodothyronine Test System

The Food and Drug Administration (FDA) is publishing a notice announcing that it has received a petition requesting exemption from the premarket notification requirements for the total triiodothyronine test system class II device (special controls). FDA is publishing this notice in order to obtain comments on this petition in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).