[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR821.20]

[Page 162]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 821_MEDICAL DEVICE TRACKING REQUIREMENTS--Table of Contents
 
                     Subpart B_Tracking Requirements
 
Sec. 821.20  Devices subject to tracking.


    (a) A manufacturer of any class II or class III device that fits 
within one of the three criteria within Sec. 821.1(a) must track that 
device in accordance with this part, if FDA issues a tracking order to 
that manufacturer.
    (b) When responding to premarket notification submissions and 
remarket approval applications, FDA will notify the sponsor by issuing 
an order that states that FDA believes the device meets the criteria of 
section 519(e)(1) of the act and, by virtue of the order, the sponsor 
must track the device.

[67 FR 5951, Feb. 8, 2002]