[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: 21CFR876.5020]

[Page 382-383]
 
                        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 F_Therapeutic Devices
 
Sec. 876.5020  External penile rigidity devices.

    (a) Identification. External penile rigidity devices are devices 
intended to

[[Page 383]]

create or maintain sufficient penile rigidity for sexual intercourse. 
External penile rigidity devices include vacuum pumps, constriction 
rings, and penile splints which are mechanical, powered, or pneumatic 
devices.
    (b) Classification. Class II (special controls). The devices are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec. 876.9. The 
special control for these devices is the FDA guidance document entitled 
``Class II Special Controls Guidance Document: External Penile Rigidity 
Devices.'' See Sec. 876.1(e) for the availability of this guidance 
document.

[69 FR 77623, Dec. 28, 2004]