Fed Regist. 1994 Jun 17;59(116):31138.
The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to general redelegations of authority from the Associate Commissioner of Regulatory Affairs to certain FDA officials in the Center for Devices and Radiological Health (CDRH). The redelegation provides these officials with authority to grant or deny certain citizen petitions for exemption or variance from medical device tracking requirements. This action is being taken to facilitate expeditious handling of citizen petitions. FDA is also issuing a conforming amendment to the medical device tracking regulations to make the regulations consistent.
美国食品药品监督管理局（FDA）正在修订有关从监管事务专员向设备与放射健康中心（CDRH）的某些FDA官员进行一般授权再委托的授权规定。该再委托赋予这些官员批准或拒绝某些公民提出的免除或偏离医疗器械追踪要求的请愿书的权力。采取这一行动是为了便于迅速处理公民请愿书。FDA还对医疗器械追踪规定发布了相应修订，以使规定保持一致。
