[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: 21CFR876.3750]

[Page 363]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 876.3750  Testicular prosthesis.

    (a) Identification. A testicular prosthesis is an implanted device 
that consists of a solid or gel-filled silicone rubber prosthesis that 
is implanted surgically to resemble a testicle.
    (b) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of product 
development protocol (PDP) is required. A PMA or notice of completion of 
a PDP is required to be filed with the Food and Drug Administration on 
or before July 5, 1995, for any testicular prosthesis that was in 
commercial distribution before May 28, 1976, or that has on or before 
July 5, 1995, been found to be substantially equivalent to a testicular 
prosthesis that was in commercial distribution before May 28, 1976. Any 
other testicular prosthesis shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 60 
FR 17216, Apr. 5, 1995]