[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: 21CFR880.5680]

[Page 385]
 
                        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. 880.5680  Pediatric position holder.

    (a) Identification. A pediatric position holder is a device used to 
hold an infant or a child in a desired position for therapeutic or 
diagnostic purposes, e.g., in a crib under a radiant warmer, or to 
restrain a child while an intravascular injection is administered.
    (b) Classification. Class I (general controls). The device 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.