[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: 21CFR5.53]

[Page 50-51]
 
                        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. 5.53  Approval, disapproval, or withdrawal of approval of product development protocols and applications for premarket approval for medical devices.

    (a) The following officials, for medical devices assigned to their 
respective organizations, are authorized to approve, disapprove, declare 
as complete or incomplete, or revoke product development protocols for 
medical devices submitted under section 515(f) of the Federal Food, 
Drug, and Cosmetic Act (the act):
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), the Director and Deputy Directors, Office of 
Device Evaluation (ODE), CDRH, and the Division Directors, ODE, CDRH.
    (2) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Director, 
Office of Biological Product Review, CBER.
    (b)(1) The following officials, for medical devices assigned to 
their respective organizations, are authorized to approve, disapprove, 
or withdraw approval of applications for premarket approval for medical 
devices submitted under sections 515 and 520(l) of the act:
    (i) The Director and Deputy Directors, CDRH, the Director and Deputy

[[Page 51]]

Directors, ODE, CDRH, and the Division Directors, ODE, CDRH.
    (ii) The Director and Deputy Director, CBER, and the Director and 
Deputy Director, Office of Biological Product Review, CBER.
    (2) For medical devices assigned to their respective division, the 
Division Directors, Office of Device Evaluation, CDRH, are authorized to 
approve, disapprove, or withdraw approval of supplemental premarket 
applications.
    (c) The Director and Deputy Directors, CDRH, for medical devices 
assigned to their organization, are authorized to issue notices to 
announce the approval, disapproval, or withdrawal of approval of a 
device, and to make publicly available a detailed summary of the 
information on which the decision was based, under sections 515(d), (e), 
and (g) and 520(h)(1) of the act.

[48 FR 56947, Dec. 27, 1983, as amended at 49 FR 14933, Apr. 16, 1984; 
49 FR 21708, May 23, 1984; 50 FR 9424, Mar. 8, 1985; 54 FR 8317, Feb. 
28, 1989; 62 FR 67271, Dec. 24, 1997; 63 FR 27207, May 18, 1998]