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FDA STAFF MANUAL GUIDES, VOLUME II - DELEGATIONS OF AUTHORITY

REGULATORY - MEDICAL DEVICES AND RADIOLOGICAL HEALTH

SMG 1410.403 - DETENTION OF ADULTERATED OR MISBRANDED MEDICAL DEVICES

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:

1. For medical devices assigned to their respective organizations:

a. The Director and Deputy Director, Center for Devices and Radiological Health (CDRH).

b. The Director and Deputy Director, Office of Compliance, the Director and Deputy Director, Office of In Vitro Diagnostic Devices Evaluation and Safety, and the Director and Deputy Director, Office of Communication, Education, and Radiation Programs, CDRH.

c. The Director and Deputy Directors, Center for Biologics Evaluation and Research (CBER).

d. The Director and Deputy Directors, Office of Compliance and Biologics Quality, CBER.

e. Regional Food and Drug Directors.

f. District Directors.

g. The Director, St. Louis Branch.

h. The Director and Deputy Director, Center for Drug Evaluation and Research (CDER)

i. The Director and Deputy Director, Office of Compliance, CDER

2. REDELEGATION.

These officials may not further redelegate this authority.

3. EFFECTIVE DATE.

This delegation was signed by Lester M. Crawford, D.V.M., Ph.D., Acting Commissioner of Food and Drugs, and became effective on March 22, 2005.

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