[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: 21CFR878.3800]

[Page 397]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878_GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                      Subpart D_Prosthetic Devices
 
Sec. 878.3800  External aesthetic restoration prosthesis.

    (a) Identification. An external aesthetic restoration prosthesis is 
a device intended to be used to construct an external artificial body 
structure, such as an ear, breast, or nose. Usually the device is made 
of silicone rubber and it may be fastened to the body with an external 
prosthesis adhesive. The device is not intended to be implanted.
    (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. 878.9. If the device 
is intended for use without an external prosthesis adhesive to fasten it 
to the body, the device is exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38802, July 25, 2001]