Zdrowie i gospodarka · 8.08.2000
Medical Devices; Exemption From Premarket Notification; Class II Devices
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 barium enema retention catheter with or without bag 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).