FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY
REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH
ISSUANCE OF FEDERAL REGISTER DOCUMENTS TO RECOGNIZE OR TO WITHDRAW RECOGNITION OF A STANDARD TO MEET PREMARKET SUBMISSION REQUIREMENTS
Effective Date: 02/10/2011
1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.
The following officials are authorized to issue Federal Register documents under Section 514(c) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360d(c)) recognizing or withdrawing recognition of a standard for which a person may submit a declaration of conformity in order to meet a premarket submission requirement.
1. Director and Deputy Directors, Center for Devices and Radiological Health
2. Director and Deputy Director, Center for Biologics Evaluation and Research
3. Director and Deputy Directors, Center for Drug Evaluation and Research
These officials may not further redelegate this authority.
3. EFFECTIVE DATE.
The Commissioner of Food and Drugs approved this delegation, via memorandum, on February 10, 2011.
|STATUS (I, R, C)||DATE APPROVED||LOCATION OF CHANGE HISTORY||CONTACT||APPROVING OFFICIAL|
|Initial||06/23/2009||N/a||OC/OO/OM/OMP||Commissioner of Food and Drugs|
|Revision||02/10/2011||N/a||CDRH/OMO/DEMO/AMB||Margaret A. Hamburg, M.D., Commissioner of Food and Drugs|