Zdrowie i gospodarka · 18/11/1998

Medical Devices; Exemptions From Premarket Notification; Class II Devices

The Food and Drug Administration (FDA) is publishing notice of a petition requesting exemption from the premarket notification requirements for a class II device, the audiometer. 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).