[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: 21CFR5.60]

[Page 53-54]
 
                        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. 5.60  Required and discretionary postmarket surveillance.

    (a) For any device (including any device that is or contains a drug 
or biologic) that was first introduced or delivered for introduction 
into interstate commerce after January 1, 1991, and that is either a 
permanent implant, the failure of which may cause serious adverse health 
consequences or death, a life-sustaining or life-supporting device, or a 
device that potentially presents a serious risk to human health, any of 
the following officials is authorized to require a manufacturer of such 
device to conduct postmarket surveillance:
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH).
    (2) The Director and Deputy Director, Office of Surveillance and 
Biometrics, CDRH.
    (3) The Director and Deputy Director, Division of Postmarket 
Surveillance, Office of Surveillance and Biometrics, CDRH.
    (4) The Director and Deputy Directors, Division Directors and 
Associate Division Directors, Office of Device Evaluation, CDRH.
    (5) The Chief, Premarket Notification Section; Chief, Premarket 
Approval Section; Director, Program Operations Staff, Office of Device 
Evaluation, CDRH.
    (6) The Director and Deputy Director, Office of Compliance, CDRH.
    (7) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (8) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (9) The Director and Deputy Director, Office of Compliance, CDER.
    (10) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (11) The Director and Deputy Director, Office of Compliance, CBER.
    (12) The Director and Deputy Director, Office of Biological Product 
Review, CBER.
    (b) For any device (including any device that is or contains a drug 
or biologic), any of the following officials is

[[Page 54]]

authorized to require a manufacturer of a device to conduct postmarket 
surveillance if the official determines that postmarket surveillance of 
the device is necessary to protect the public health or provide safety 
or effectiveness data for the device:
    (1) The Director and Deputy Directors, CDRH.
    (2) The Director and Deputy Director, Office of Surveillance and 
Biometrics, CDRH.
    (3) The Director and Deputy Director, Division of Postmarket 
Surveillance, Office of Surveillance and Biometrics, CDRH.
    (4) The Director and Deputy Directors, Office of Device Evaluation, 
CDRH.
    (5) The Director and Deputy Director, Office of Compliance, CDRH.
    (6) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER.
    (7) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (8) The Director and Deputy Director, Office of Compliance, CDER.
    (9) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (10) The Director and Deputy Director, Office of Compliance, CBER.
    (11) The Director and Deputy Director, Office of Biological Product 
Review, CBER.

[57 FR 40315, Sept. 3, 1992, as amended at 62 FR 2556, Jan. 17, 1997; 62 
FR 67272, Dec. 24, 1997]