[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5160]

[Page 382]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
    Subpart F--General Hospital and Personal Use Therapeutic Devices
 
Sec. 880.5160  Therapeutic medical binder.

    (a) Identification. A therapeutic medical binder is a device, 
usually made of cloth, that is intended for medical purposes and that 
can be secured by ties so that it supports the underlying part of the 
body or holds a dressing in place. This generic type of device includes 
the abdominal binder, breast binder, and perineal binder.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notifiction procedures in subpart E of part 807. If 
the device is not labeled or otherwise represented as sterile, it also 
is exempt from the good manufacturing practice regulation in part 820, 
with the exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.