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SMG 1410.403

FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

DETENTION OF ADULTERATED OR MISBRANDED MEDICAL DEVICES

Effective Date: 02/10/2011

[PDF Version]

1. AUTHORITY DELEGATED AND TO WHOM DELEGATED.

The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs pertaining to detention, under Section 304(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334(g)) and in accordance with 21 CFR, Part 800, Section 800.55 of 21 CFR, of medical devices that may be adulterated or misbranded: For medical devices assigned to their respective organizations:

1. Director and Deputy Directors, Center for Devices and Radiological Health (CDRH), Director and Deputy Directors, Office of Compliance, CDRH

2. Director and Deputy Directors, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH; Director and Deputy Directors, Office of Device Evaluation, CDRH; Director and Deputy Directors, Office of Communication, Education, and Radiation Programs, CDRH

3. Director and Deputy Director, Center for Biologics Evaluation and Research (CBER)

4. Director and Deputy Directors, Office of Compliance and Biologics Quality, (CBER)

5. Regional Food and Drug Directors, ORA

6. District Directors, ORA

7. Director and Deputy Directors, Center for Drug Evaluation and Research (CDER)

8. Director and Deputy Director, Office of Compliance, (CDER)

2. REDELEGATION.

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 APPROVEDLOCATION OF CHANGE HISTORYCONTACTAPPROVING OFFICIAL
Initial06/23/2009N/aOC/OO/OM/OMPCommissioner of Food and Drugs
Revision02/10/2011N/aCDRH/OMO/DEMO/AMBMargaret A. Hamburg, M.D., Commissioner of Food and Drugs