[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.405]

[Page 78]
 
                        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 F_Medical Devices and Radiological Health; Redelegations of 
                                Authority
 
Sec. 5.405  Determination of classification of devices.

    (a) The following officials, for devices assigned to their 
respective organizations, are authorized to determine the classification 
of a medical device in commercial distribution prior to May 28, 1976, 
under section 513(d) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360c(d)):
    (1) The Director and Deputy Directors for Science and for 
Regulations and Policy, Center for Devices and Radiological Health 
(CDRH) and the Director and Deputy Directors, Office of Device 
Evaluation (ODE), CDRH.
    (2) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Directors of 
the Office of Blood Research and Review (OBRR), the Office of Vaccines 
Research and Review (OVRR), and the Office of Therapeutics Research and 
Review (OTRR), CBER.
    (b) The following officials, for devices assigned to their 
respective organizations, are authorized to determine the classification 
of a medical device first intended for commercial distribution after May 
28, 1976, under section 513(f)(1)(A) of the act (21 U.S.C. 
360c(f)(1)(A)):
    (1) The Director and Deputy Directors for Science and for 
Regulations and Policy, CDRH, and the Director, Deputy Directors, 
Division and Deputy Division Directors, Associate Division Directors, 
Branch Chiefs, and Chief, Premarket Notification Section, ODE, CDRH.
    (2) The Director and Deputy Directors, CBER, and the Directors and 
Deputy Directors of the OBRR, OVRR, and OTRR, CBER.
    (c) The following officials are authorized to make determinations 
and issue orders classifying devices under section 513(f)(2)(b):
    (1) The Director and Deputy Directors for Science and for 
Regulations and Policy, CDRH.
    (2) The Director and Deputy Directors, ODE, CDRH.
    (3) The Director and Deputy Directors, CBER, and the Directors and 
Deputy Directors of the OBRR, OVRR, and OTRR, CBER.
    (d) The Director and Deputy Directors for Science and for 
Regulations and Policy, CDRH, and the Director and Deputy Directors, 
CBER, and the Directors and Deputy Directors of the OBRR, OVRR, and 
OTRR, CBER, are authorized to issue Federal Register notices under 
section 513(f)(2)(C) of the act (21 U.S.C. 360c(f)(2)(C)) announcing 
classification of devices under section 513(f)(2)(B) of the act (21 
U.S.C. 360c(f)(2)(B)).
    (e) These officials may not further redelegate those authorities.