[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: 21CFR890.3410]

[Page 481-482]
 
                        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. 890.3410  External limb orthotic component.

    (a) Identification. An external limb orthotic component is a device 
intended for medical purposes for use in conjunction with an orthosis 
(brace) to increase the function of the orthosis for a patient's 
particular needs. Examples of external limb orthotic components include 
the following: A brace-setting twister and an external brace stirrup.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820, with the exception of Sec. 820.180, with

[[Page 482]]

respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.