[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: 21CFR876.5540]

[Page 369-370]
 
                        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. 876.5540  Blood access device and accessories.

    (a) Identification. A blood access device and accessories is a 
device intended to provide access to a patient's blood for hemodialysis 
or other chronic uses. When used in hemodialysis, it is part of an 
artificial kidney system for the treatment of patients with renal 
failure or toxemic conditions and provides access to a patient's blood 
for hemodialysis. The device includes implanted blood access devices, 
nonimplanted blood access devices, and accessories for both the 
implanted and nonimplanted blood access devices.
    (1) The implanted blood access device consists of various flexible 
or rigid

[[Page 370]]

tubes, which are surgically implanted in appropriate blood vessels, may 
come through the skin, and are intended to remain in the body for 30 
days or more. This generic type of device includes various shunts and 
connectors specifically designed to provide access to blood, such as the 
arteriovenous (A-V) shunt cannula and vessel tip.
    (2) The nonimplanted blood access device consists of various 
flexible or rigid tubes, such as catheters, cannulae or hollow needles, 
which are inserted into appropriate blood vessels or a vascular graft 
prosthesis (Secs. 870.3450 and 870.3460), and are intended to remain in 
the body for less than 30 days. This generic type of device includes 
fistula needles, the single needle dialysis set (coaxial flow needle), 
and the single needle dialysis set (alternating flow needle).
    (3) Accessories common to either type include the shunt adaptor, 
cannula clamp, shunt connector, shunt stabilizer, vessel dilator, 
disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, 
joint ring, fistula adaptor, and declotting tray (including contents).
    (b) Classification. (1) Class III (premarket approval) for the 
implanted blood access device.
    (2) Class II (performance standards) for the nonimplanted blood 
access device.
    (3) Class II (performance standards) for accessories for both the 
implanted and the nonimplanted blood access devices not listed in 
paragraph (b)(4) of this section.
    (4) Class I for the cannula clamp, disconnect forceps, crimp plier, 
tube plier, crimp ring, and joint ring, accessories for both the 
implanted and nonimplanted blood access device. The devices subject to 
this paragraph (b)(4) are exempt from the premarket notification 
procedures in subpart E of part 807 of this chapter subject to the 
limitations in Sec. 876.9.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval for the device described in paragraph (b)(1). See Sec. 876.3.

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 
FR 1122, Jan. 16, 1996; 66 FR 38802, July 25, 2001]