Zdrowie i gospodarka · 24/10/2006

Medical Devices; Exemptions From Premarket Notification; Class II Devices

The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for cranial orthosis type devices. These devices are used to improve cranial symmetry in neonates. FDA is publishing this notice in order to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).