[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.3150]

[Page 500-501]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 890--PHYSICAL MEDICINE DEVICES--Table of Contents
 
             Subpart D--Physical Medicine Prosthetic Devices
 
Sec. 890.3150  Crutch.

    (a) Identification. A crutch is a device intended for medical 
purposes for use by disabled persons to provide minimal to moderate 
weight support while walking.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 890.9. The device is 
also exempt from the current

[[Page 501]]

good manufacturing practice regulations in part 820 of this chapter, 
with the exception of Sec. 820.180, regarding general requirements 
concerning records and Sec. 820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001]