FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY
REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH
ISSUANCE OF FEDERAL REGISTER DOCUMENTS PERTAINING TO PREMARKET SUBMISSION REQUIREMENTS AND EXEMPTION FROM PREMARKET NOTIFICATION
Effective Date: 02/10/2011
1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.
The following officials are authorized to make determinations and issue Federal Register notices and rules under Section 510(m) of the Federal Food Drug and Cosmetic Act (21 U.S.C. 360(m)) concerning exemptions from premarket notification.
1. Director and Deputy Directors, Center for Devices and Radiological Health
2. Directors 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|