Zdrowie i gospodarka · 29.09.1998
Medical Devices; Exemptions From Premarket Notification; Class II Devices
The Food and Drug Administration (FDA) is publishing an order denying four petitions requesting exemptions for five devices from the premarket notification requirements for certain class II devices. FDA is publishing this notice in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).