[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: 21CFR876.5250]

[Page 367-368]
 
                        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. 876.5250  Urine collector and accessories.

    (a) Identification. A urine collector and accessories is a device 
intended to collect urine. The device and accessories consist of tubing, 
a suitable receptacle, connectors, mechanical supports, and may include 
a means to prevent the backflow of urine or ascent of infection. The two 
kinds of urine collectors are:
    (1) A urine collector and accessories intended to be connected to an 
indwelling catheter, which includes the urinary drainage collection kit 
and the closed urine drainage system and drainage bag; and
    (2) A urine collector and accessories not intended to be connected 
to an indwelling catheter, which includes the corrugated rubber sheath, 
pediatric urine collector, leg bag for external use, urosheath type 
incontinence device, and the paste-on device for incontinence.
    (b) Classification. (1) Class II (special controls) for a urine 
collector and accessories intended to be connected to an indwelling 
catheter. The device is exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to 
Sec. 876.9.

[[Page 368]]

    (2) Class I (general controls). For a urine collector and 
accessories not intended to be connected to an indwelling catheter, 
subject to the limitations in Sec. 876.9. If the device is not labeled 
or otherwise represented as sterile, it 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.

[48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998; 65 
FR 2317, Jan. 14, 2000; 66 FR 38802, July 25, 2001]