Zdrowie i gospodarka · 26/12/2006

Medical Devices; Exemptions from Premarket Notification; Class II Devices

The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption for cranial orthosis type devices from the premarket notification requirements for certain class II devices. A cranial orthosis device is a device intended to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry or shape. FDA is publishing this notice in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).