[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: 21CFR890.3475]

[Page 521-522]
 
                        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. 890.3475  Limb orthosis.

    (a) Identification. A limb orthosis (brace) is a device intended for 
medical purposes that is worn on the upper or lower extremities to 
support, to correct, or to prevent deformities or to align body 
structures for functional

[[Page 522]]

improvement. Examples of limb orthoses include the following: A whole 
limb and joint brace, a hand splint, an elastic stocking, a knee cage, 
and a corrective shoe.
    (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 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]