[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.55]

[Page 51]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
Subpart B--Redelegations of Authority from the Commissioner of Food and 
                                  Drugs
 
Sec. 5.55  Orders to repair or replace, or make refunds for, medical devices.

    The following officials, for medical devices assigned to their 
respective organizations, are authorized to order repair or replacement 
of, or refund for, medical devices under section 518 (b) and (c) of the 
Federal Food, Drug, and Cosmetic Act:
    (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Director, Office 
of Compliance, CDRH.
    (b) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Compliance, CBER.
    (c) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); and the Director and Deputy Director, 
Office of Compliance, CDER.

[48 FR 56948, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984; 
57 FR 40317, Sept. 3, 1992; 62 FR 2556, Jan. 17, 1997; 62 FR 67272, Dec. 
24, 1997]