21 Food and Drugs 1 2000-04-01 2000-04-01 false Authority relating to determination of product primary jurisdiction. 5.32 Section 5.32 Food and Drugs FOOD AND DRUG ADMINISTRATION,DEPARTMENT OF HEALTH ANDHUMAN SERVICES GENERAL DELEGATIONS OF AUTHORITY AND ORGANIZATION Redelegations of Authority from the Commissioner of Food and Drugs
ยง 5.32 Authority relating to determination of product primary jurisdiction.

The FDA ombudsman as product jurisdiction officer is authorized to determine whether the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), or the Center for Drug Evaluation and Research (CDER) has primary responsibility for premarket review and regulation of a product that constitutes a combination of a drug, device, or biological product under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act or that is a drug, device or biologic product where the center with primary jurisdiction is unclear or in dispute.

[56 FR 58758, Nov. 21, 1991]