Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.
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.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D017146:Models, Organizational; D011358:Product Surveillance, Postmarketing / Q000592:standards; D013679:Technology, Radiologic / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*