Fed Regist. 1991 Oct 10;56(197):51169-70.
The Commissioner of Food and Drugs is redelegating authorities to certain officials of the Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) to temporarily suspend premarket approval applications and to recall devices in the event those devices would cause serious adverse consequences to health or death. These authorities were given to the FDA by the Safe Medical Devices Act of 1990.
食品药品专员正在将相关权力重新委托给食品药品管理局(FDA)设备与放射健康中心(CDRH)的某些官员,以便在某些医疗器械可能对健康造成严重不良后果或导致死亡的情况下,临时中止其上市前批准申请并召回这些器械。这些权力是1990年《安全医疗器械法案》赋予FDA的。