Document ID: FDA-2012-N-0303-0003
Agency: fda
Document Type: Proposed Rule
Title: Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
Posted Date: 2013-06-28T04:00Z

[Federal Register Volume 78, Number 125 (Friday, June 28, 2013)]
[Proposed Rules]
[Pages 38867-38872]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15504]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2012-N-0303]

Gastroenterology-Urology Devices; Reclassification of Implanted 
Blood Access Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed 
administrative order to reclassify the implanted blood access device 
preamendments class III device into class II (special controls) and 
subject to premarket notification, and to further clarify the 
identification. FDA is proposing this reclassification under the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) based on new 
information pertaining to the device. This action implements certain 
statutory requirements.

DATES: Submit either electronic or written comments on the proposed 
order by July 29, 2013. See section XII for the proposed effective date 
of any final order that may publish based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0303, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2012-N-0303 for this order. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993, 301-796-6527.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The FD&C Act establishes a comprehensive system for the regulation 
of medical devices intended for human use. Section 513 of the FD&C Act 
(21 U.S.C. 360c) established three categories (classes) of devices, 
reflecting the regulatory controls needed to provide reasonable 
assurance of their safety and effectiveness. The three categories of 
devices are class I (general controls), class II (special controls), 
and class III (premarket approval).
    Under section 513 of the FD&C Act, devices that were in commercial 
distribution before the enactment of the 1976 amendments, May 28, 1976 
(generally referred to as preamendments devices), are classified after 
FDA has: (1) Received a recommendation from a device classification 
panel (an FDA advisory committee); (2) published the panel's 
recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976 (generally referred to as postamendments devices), are 
automatically classified by section 513(f) of the FD&C Act into class 
III without any FDA rulemaking process. Those devices remain in class 
III and require premarket approval unless, and until, the device is 
reclassified into class I or II or FDA issues an order finding the 
device to be substantially equivalent, in accordance with section 
513(i) of the FD&C Act, to a predicate device that does not require 
premarket approval. The Agency determines whether new devices are 
substantially equivalent to predicate devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and part 807 (21 CFR Part 807).
    On July 9, 2012, the Food and Drug Administration Safety and 
Innovation Act (FDASIA) was enacted. Section 608(a) of FDASIA (126 
Stat. 1056) amended the device reclassification procedures under 
section 513(e) of the FD&C Act, changing the process for reclassifying 
a device from rulemaking to an administrative order. Prior to the 
enactment of FDASIA, FDA published a proposed rule under section 513(e) 
proposing the reclassification of implanted blood access devices for 
hemodialysis (77 FR 36951; June 20, 2012). FDA is issuing this proposed 
administrative order to comply with the new procedural requirement 
created by FDASIA when reclassifying a preamendments class III device. 
Also as required by section 513(e) of the FD&C Act, FDA has scheduled a 
panel meeting to discuss the proposed reclassification for June 27, 
2013 (78 FR 25747; May 2, 2013). The three comments submitted in 
response to the proposed rule on implanted blood access devices for 
hemodialysis will be considered under this proposed administrative 
order and do not need to be resubmitted. No objections to the proposed 
reclassification were submitted. This

[[Page 38868]]

action is intended solely to fulfill the procedural requirements for 
reclassification implemented by FDASIA. FDA is also issuing the draft 
guidance, ``Implanted Blood Access Devices for Hemodialysis,'' which 
provides recommendations on how to comply with the special controls 
that are necessary to provide a reasonable assurance of the safety and 
effectiveness of the device.
    Section 513(e) of the FD&C Act provides that FDA may, by 
administrative order, reclassify a device based upon ``new 
information.'' FDA can initiate a reclassification under section 513(e) 
or an interested person may petition FDA to reclassify a preamendments 
device. The term ``new information,'' as used in section 513(e) of the 
FD&C Act, includes information developed as a result of a reevaluation 
of the data before the Agency when the device was originally 
classified, as well as information not presented, not available, or not 
developed at that time. (See, e.g., Holland-Rantos Co. v. United States 
Dep't of Health, Educ., & Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 
1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 
366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 
F.Supp. 382, 388-391 (D.D.C. 1991)), or in light of changes in 
``medical science.'' (See Upjohn v. Finch supra, 422 F.2d at 951.) 
Whether data before the Agency are old or new data, the ``new 
information'' to support reclassification under section 513(e) must be 
``valid scientific evidence,'' as defined in section 513(a)(3) of the 
FD&C Act and Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g., 
General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens 
Association v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 
U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the valid scientific 
evidence upon which the Agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
premarket approval application (PMA). (See section 520(c) of the FD&C 
Act (21 U.S.C. 360j(c)).) Section 520(h)(4) of the FD&C Act, added by 
the Food and Drug Administration Modernization Act of 1997 (FDAMA), 
provides that FDA may use, for reclassification of a device, certain 
information in a PMA 6 years after the application has been approved. 
This includes information from clinical and preclinical tests or 
studies that demonstrate the safety or effectiveness of the device, but 
does not include descriptions of methods of manufacture or product 
composition and other trade secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for 
issuing a final order. Specifically, prior to the issuance of a final 
order reclassifying a device, the following must occur: (1) Publication 
of a proposed order in the Federal Register; (2) a meeting of a device 
classification panel described in section 513(b) of the FD&C Act; and 
(3) consideration of comments from all affected stakeholders, including 
patients, payors, and providers. In addition, the proposed order must 
set forth the proposed reclassification, and a substantive summary of 
the valid scientific evidence concerning the proposed reclassification, 
including the public health benefits of the use of the device, and the 
nature and incidence (if known) of the risk of the device. (See section 
513(e)(1)(A)(i) of the FD&C Act.)
    FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the 
FD&C Act provides that a class II device may be exempted from the 
premarket notification requirements under section 510(k) of the FD&C 
Act if the Agency determines that premarket notification is not 
necessary to assure the safety and effectiveness of the device.

II. Regulatory History of the Device

    As discussed in the preamble to the proposed rule (46 FR 7616; 
January 23, 1981), the Gastroenterology-Urology Devices Panel 
recommended that both implanted and nonimplanted blood access devices 
be classified into class II. Although FDA agreed with the panel 
recommendation for nonimplanted blood access devices, FDA disagreed 
with the panel for implanted blood access devices and proposed that 
implanted blood access devices be classified into class III because FDA 
believed that the device presented a potential unreasonable risk of 
illness or injury to the patient. FDA also noted that the implanted 
blood access device is part of a life-supporting and life-sustaining 
system and that general controls and performance standards were 
insufficient to provide reasonable assurance of the safety and 
effectiveness of implanted blood access devices.
    In 1983, FDA classified implanted blood access devices into class 
III, but the accessories to these devices into class II (48 FR 53012; 
November 23, 1983). In 1987, FDA published a clarification by inserting 
language in the codified language stating that no effective date had 
been established for the requirement for premarket approval for 
implanted blood access devices (52 FR 17732 at 17738; May 11, 1987).
    In 2009, FDA published an order for the submission of information 
on implanted blood access devices (74 FR 16214; April 9, 2009). In 
response to that order, FDA received information in support of 
reclassification from 15 device manufacturers who all recommended that 
implanted blood access devices be reclassified to class II. The 
manufacturers stated that safety and effectiveness of these devices may 
be assured by bench testing, biocompatibility testing, sterility 
testing, expiration date testing, labeling, and standards.
    On June 20, 2012, FDA published a proposed rule proposing the 
reclassification of implanted blood access devices for hemodialysis 
from class III to class II (77 FR 36951) and announced the availability 
of a draft Special Controls Guidance Document that, when finalized, 
would serve as a special control, if FDA reclassified these devices. 
FDA believed that the special controls as described in the guidance 
document entitled ``Class II Special Controls Guidance Document: 
Implanted Blood Access Devices for Hemodialysis'' would be sufficient 
to mitigate the risks to health associated with implanted blood access 
devices for hemodialysis.
    The proposed rule provided for a comment period that was open until 
September 18, 2012. FDA received three comments that suggested 
modifications to the proposed Special Controls Guidance Document. These 
were considered by FDA.
    On July 9, 2012, FDASIA was enacted, which amended the device 
reclassification procedures under sections 513 and 515 of the FD&C Act 
(21 U.S.C. 360c and 360e, respectively), changing the process for 
taking final administrative action for these devices. Accordingly, FDA 
is issuing a proposed administrative order to comply with the new 
procedural requirement created by FDASIA when reclassifying a 
preamendments class III device. Further, FDA intends to codify the 
proposed special controls within the Sec.  876.5540(b)(1) (21 CFR 
876.5540(b)(1)) classification regulation.

III. Device Description

    Implanted blood access devices include various flexible or rigid 
tubes,

[[Page 38869]]

such as catheters or cannulae. Chronic hemodialysis catheters are soft, 
blunt-tipped plastic catheters that have a subcutaneous ``cuff'' for 
tissue ingrowth. They are placed in a central vein to allow blood 
access. Chronic hemodialysis catheters serve as conduits for the 
removal of blood from the patient, delivery to a hemodialysis machine 
for filtering, and return of filtered blood to the patient. They have 
no moving parts, consisting, essentially, of flexible tubing 
terminating in rigid Luer lock connectors for attachment to a dialysis 
machine. Subcutaneous catheters are totally implanted below the skin 
surface with no external communication. Arteriovenous shunts and vessel 
tips are tubing with tapered tips that are inserted into the artery and 
vein. The tubing is attached to the roughened or etched outer surface 
of the tip. The tubing is external to the skin and can be accessed with 
needles.
    FDA is proposing in this order to modify the identification 
language from how it is presently written in Sec.  876.5540(a)(1) for 
additional clarification. FDA is clarifying in the identification that 
these are prescription devices and modifying the examples of devices 
(e.g., catheter, cannulae) in the identification language to be 
consistent with existing legally marketed devices covered by this 
classification.

IV. Proposed Reclassification

    FDA is proposing that implanted blood access devices for 
hemodialysis be reclassified from class III to class II. In this 
proposed order, the Agency has identified special controls under 
section 513(a)(1)(B) of the FD&C Act that, together with general 
controls (including prescription-use restrictions) applicable to the 
devices, would provide reasonable assurance of their safety and 
effectiveness. Absent the special controls identified in this proposed 
order, general controls applicable to the device are insufficient to 
provide reasonable assurance of the safety and effectiveness of the 
device. FDA believes that this new information is sufficient to 
demonstrate that the proposed special controls can effectively mitigate 
the risks to health identified in the next section, and that these 
special controls, together with general controls, will provide a 
reasonable assurance of safety and effectiveness for implanted blood 
access devices.
    FDA believes that these devices can be utilized to provide access 
to a patient's blood for hemodialysis or other chronic uses for 30 days 
or more. When used in hemodialysis, the device 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.
    FDA has considered implanted blood access devices in accordance 
with the reserved criteria set forth in section 510(l) and decided that 
the device requires premarket notification (510(k) of the FD&C Act). 
Therefore, the Agency does not intend to exempt this proposed class II 
device from premarket notification (510(k)) submission as provided 
under section 510(m) of the FD&C Act.

V. Risks to Health

    After considering available information for the classification of 
these devices, FDA has evaluated the risks to health associated with 
the use of implanted blood access devices for hemodialysis and 
determined the following risks to health are associated with its use:
     Thrombosis in patient and catheter occlusion, or central 
venous stenosis. Inadequate blood compatibility of the materials used 
in this device, blood pooling between dialysis sessions, or turbulent 
blood pathways could lead to potentially debilitating or fatal 
thromboembolism.
     Adverse tissue reaction. Inadequate tissue compatibility 
of the materials used in this device could cause an immune reaction.
     Infection and pyrogen reactions. An improperly sterilized 
device could cause a skin or bloodstream infection.
     Device failure. Weakness of connections or materials could 
lead to blood loss or device fragment embolization.
     Cardiac arrhythmia, hemorrhage, embolism, nerve injury, or 
vessel perforation. Improper placement into the heart or blood vessel 
could damage tissues and result in injuries.
     Hemolysis. Turbulence or high pressure created by narrow 
openings or changes in blood flow paths could cause the destruction of 
red blood cells.
     Accidental withdrawal or catheter migration. A catheter's 
cuff may not allow adequate ingrowth from the surrounding subcutaneous 
tissue, which could cause the device to dislodge or fall out with 
subsequent blood loss.

VI. Summary of Reasons for Reclassification

    FDA believes that implanted blood access devices for hemodialysis 
should be reclassified from class III to class II because special 
controls, in addition to general controls, can be established to 
provide reasonable assurance of the safety and effectiveness of the 
device, and because general controls themselves are insufficient to 
provide reasonable assurance of its safety and effectiveness. In 
addition, there is now sufficient information to establish special 
controls to provide such assurance.
    While current clinical practice guidelines recommend avoiding 
implanted blood access devices, such as catheters, if possible, they 
are still a necessary treatment option, and are used in a significant 
number of hemodialysis patients. While the risks are frequently cited, 
there are many advantages of implanted blood access devices, which lead 
to their relatively frequent use, as described previously. In many 
cases, vascular access for hemodialysis is needed urgently, and the 
alternatives, such as the arteriovenous fistula or the arteriovenous 
graft require weeks and months, respectively, before they can be used. 
Implanted blood access devices are frequently used as the immediate 
hemodialysis vascular access and also as a bridge to a more permanent 
vascular access. Additionally, some patients may have inadequate 
vascular anatomy to establish a more permanent vascular access and may 
require continued implanted blood access device use.

VII. Summary of Data Upon Which the Reclassification Is Based

    FDA believes that the identified special controls, in addition to 
general controls, are necessary to provide reasonable assurance of 
safety and effectiveness of these devices. Therefore, in accordance 
with sections 513(e) and 515(i) of the FD&C Act and Sec.  860.130, 
based on new information with respect to the device and taking into 
account the public health benefit of the use of the device and the 
nature and known incidence of the risk of the device, FDA, on its own 
initiative, is proposing to reclassify this preamendments class III 
device into class II. The Agency has identified special controls that 
would provide reasonable assurance of their safety and effectiveness. 
Implanted blood access devices for hemodialysis are prescription 
devices restricted to patient use only upon the authorization of a 
practitioner licensed by law to administer or use the device (proposed 
Sec.  876.5540(a); Sec.  801.109 (21 CFR 801.109) (Prescription 
devices.)).
    Since 1983 when FDA classified implanted blood access devices into 
class III, sufficient evidence has been developed to support a 
reclassification to class II with special controls. FDA has been 
reviewing these devices for many years and their risks are well

[[Page 38870]]

known. The risks to health are identified in section V, and FDA 
believes these risks can be adequately mitigated by special controls. 
Catheters continue to evolve over time with improved materials and 
insertion techniques to mitigate the risks. A review of 15 publications 
shows a decrease in infections and an increase in patency over three 
decades (1980 to 2011) (Refs. 1 to 15). The decrease in occurrence of 
serious adverse events as evidenced through FDA's Manufacturer and User 
Facility Device Experience (MAUDE) database, the valid scientific 
evidence to support implanted blood access devices for hemodialysis 
provided in the referenced publications, and FDA's review experience 
with these devices, supports FDA's conclusion that the identified 
special controls, including performance testing demonstrating that the 
device performs as intended under anticipated conditions of use, is 
appropriately designed, and includes adequate safeguards and labeling 
to inform users of inappropriate use conditions, in addition to general 
controls, provide reasonable assurance of the safety and effectiveness 
of implanted blood access devices.

VIII. Proposed Special Controls

    FDA believes that the following special controls, together with 
general controls (including applicable prescription-use restrictions 
and continuing 510(k) notification requirements), are sufficient to 
mitigate the risks to health described in section V for implanted blood 
access devices:
    1. Components of the device that come into human contact must be 
demonstrated to be biocompatible. Material names and specific 
designation numbers must be provided.
    2. Performance data must demonstrate that the device performs as 
intended under anticipated conditions of use. The following performance 
characteristics must be tested:
    a. Pressure versus flow rates for both arterial and venous lumens, 
from the minimum flow rate to the maximum flow rate in 100 ml/min 
increments, must be established. The fluid and its viscosity used 
during testing must be stated.
    b. Recirculation rates for both forward and reverse flow 
configurations must be established, along with the protocol used to 
perform the assay, which must be provided.
    c. Priming volumes must be established.
    d. Tensile testing of joints and materials must be conducted. The 
minimum acceptance criteria must be adequate for its intended use.
    e. Air leakage testing and liquid leakage testing must be 
conducted.
    f. Testing of the repeated clamping of the extensions of the 
catheter that simulates use over the life of the catheter must be 
conducted, and retested for leakage.
    g. Mechanical hemolysis testing must be conducted.
    h. Chemical tolerance of the catheter to repeated exposure to 
commonly used disinfection agents must be established.
    3. Performance data must demonstrate the sterility of the device.
    4. Performance data must support the shelf life of the device for 
continued sterility, package integrity, and functionality over the 
requested shelf life that must include tensile, repeated clamping, and 
leakage testing.
    5. Labeling must bear all information required for the safe and 
effective use of implanted blood access devices for hemodialysis 
including the following:
    a. Labeling must provide arterial and venous pressure versus flow 
rates, either in tabular or graphical format.
    b. Labeling must provide the arterial and venous priming volumes.
    c. Labeling must specify the forward and reverse recirculation 
rates.
    d. Labeling must specify an expiration date.
    e. Labeling must identify any disinfecting agents that cannot be 
used to clean any components of the device.
    f. Any contraindicated disinfecting agents due to material 
incompatibility must be identified by printing a warning on the 
catheter. Alternatively a label can be provided that can be affixed to 
the patient's medical record with this information.
    g. The labeling must contain the following information: 
Comprehensive instructions for the preparation and insertion of the 
hemodialysis catheter, including recommended site of insertion, method 
of insertion, a reference on the proper location for tip placement, a 
method for removal of the catheter, anticoagulation, guidance for 
management of obstruction and thrombus formation, and site care.
    h. The labeling must identify any coatings or additives and 
summarize the results of performance testing for any coating or 
material with special characteristics, such as decreased thrombus 
formation or antimicrobial properties.
    6. For subcutaneous devices, the recommended type of needle for 
access must be described, stated in the labeling, and test results on 
repeated use of the ports must be provided.
    7. Coated devices must include a description of the coating or 
additive material, duration of effectiveness, how the coating is 
applied, and testing to adequately demonstrate the performance of the 
coating.
    In addition, implanted blood access devices are prescription 
devices restricted to patient use only upon the authorization of a 
practitioner licensed by law to administer or use the device. (Proposed 
Sec.  876.5540(a); Sec.  801.109 (Prescription devices.)). Under 21 CFR 
807.81, the device would continue to be subject to 510(k) notification 
requirements. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of a draft guidance document entitled 
``Implanted Blood Access Devices for Hemodialysis,'' that, when 
finalized, would provide recommendations on how to comply with the 
special controls proposed in this order, if FDA reclassifies this 
device (Ref. 16).

IX. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

X. Paperwork Reduction Act of 1995

    This proposed order refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in part 807, subpart E, have been approved 
under OMB control number 0910-0120; the collections of information in 
21 CFR Part 814, subpart B, have been approved under OMB control number 
0910-0231; and the collections of information under 21 CFR Part 801 
have been approved under OMB control number 0910-0485.

XI. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act 
provided for FDA to issue regulations to reclassify devices. Although 
section 513(e) as amended requires FDA to issue final orders rather 
than regulations, FDASIA also provides for FDA to revoke previously 
issued regulations by order. FDA will continue to codify 
classifications and reclassifications in the Code of Federal 
Regulations (CFR). Changes resulting from final orders will appear in 
the CFR as changes to codified classification determinations or as 
newly codified orders. Therefore, under

[[Page 38871]]

section 513(e)(1)(A)(i), as amended by FDASIA, in this proposed order 
we are proposing to revoke the requirements in Sec.  876.5540(b)(1) 
related to the classification of implanted blood access devices as 
class III devices and to codify the reclassification of implanted blood 
access devices into class II (special controls).

XII. Proposed Effective Date

    FDA is proposing that any final order based on this proposed order 
become effective on the date of its publication in the Federal Register 
or at a later date if stated in the final order.

XIII. Comments

    Comments submitted to the previous dockets (2012-N-0303) have been 
officially noted and do not need to be resubmitted. FDA will consider 
previous docket comments in issuing any final orders for these devices. 
Interested persons may submit either electronic comments regarding this 
document or the associated guidance to http://www.regulations.gov or 
written comments to the Division of Dockets Management (see ADDRESSES). 
It is only necessary to send one set of comments. Identify comments 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday, and will 
be posted to the docket at http://www.regulations.gov.

XIV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES), and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov.

1. Eisenhauer, E.D., R.J. Derveloy, and P.R. Hastings, ``Prospective 
Evaluation of Central Venous Pressure (CVP) Catheters in a Large 
City-County Hospital,'' Annals of Surgery, vol. 196, pp. 560-564, 
1982.
2. Vanholder, V., N. Hoenich, and S. Ringoir, ``Morbidity and 
Mortality of Central Venous Catheter Hemodialysis: A Review of 10 
Years' Experience,'' Nephron, vol. 47, pp. 274-279, 1987.
3. Almirall, J., J. Gonzalez, J. Rello, et al., ``Infection of 
Hemodialysis Catheters: Incidence and Mechanisms,'' American Journal 
of Nephrology, vol. 9, pp. 454-459, 1989.
4. Boyle, M.J., W.F. Gawley, D.P. Hickey, et al., ``Experience Using 
the Quinton Permcath for Haemodialysis in the Irish Republic,'' 
Nephrology Dialysis Transplantation, vol. 12, pp. 1934-1939, 1997.
5. Randolph, A.G., D.J. Cook, C.A. Gonzales, et al., ``Ultrasound 
Guidance for Placement of Central Venous Catheters: A Meta-Analysis 
of the Literature,'' Critical Care Medicine, vol. 24, pp. 2053-2058, 
1996.
6. Arnold, W.P., ``Improvement in Hemodialysis Vascular Access 
Outcomes in a Dedicated Access Center, Seminars in Dialysis, vol. 
13, pp. 359-363, 2000.
7. Wivell, W., M.A. Bettmann, B. Baxter, et al., ``Outcomes and 
Performance of the Tesio Twin Catheter System Placed for 
Hemodialysis Access,'' Radiology, vol. 221, pp. 697-703, 2001.
8. Lund, G.B., S.O. Trerotola, P.F. Scheel, Jr, et al., ``Outcome of 
Tunneled Hemodialysis Catheters Placed by Radiologists,'' Radiology, 
vol. 198, pp. 467-472, 1996.
9. Trerotola, S.O., M.S. Johnson, V.J. Harris, et al., ``Outcome of 
Tunneled Hemodialysis Catheters Placed via the Right Internal 
Jugular Vein by Interventional Radiologists,'' Radiology, vol. 203, 
pp. 489-495, 1997.
10. Prabhu, P.N., S.R. Kerns, F.W. Sabatelli, et al., ``Long-Term 
Performance and Complications of the Tesio Twin Catheter System for 
Hemodialysis Access,'' American Journal of Kidney Diseases, vol. 30, 
pp. 213-218, 1997.
11. Schnabel, K.J., M.E. Simons, G.F. Zevallos, et al., ``Image-
Guided Insertion of the Uldall Tunneled Hemodialysis Catheter: 
Technical Success and Clinical Follow-Up,'' Journal of Vascular and 
Interventional Radiology, vol. 8, pp. 579-586, 1997.
12. Nassar, G.M. and J.C. Ayus, ``Infectious Complications of the 
Hemodialysis Access,'' Kidney International, vol. 60, pp. 1-13, 
2001.
13. Power, A., S.K. Singh, D. Ashby, et al., ``Long-term Tesio 
Catheter Access for Hemodialysis Can Deliver High Dialysis Adequacy 
With Low Complication Rates,'' Journal of Vascular and 
Interventional Radiology, vol. 22, pp. 631-637, 2011.
14. Duncan, N.D., S. Singh, T.D. Cairns, et al., ``Tesio-Caths 
Provide Effective and Safe Long-Term Vascular Access,'' Nephrology 
Dialysis Transplantation, vol. 19, pp. 2816-2822, 2004.
15. Eisenstein, I., M. Tarabeih, D. Magen, et al., ``Low Infection 
Rates and Prolonged Survival Times of Hemodialysis Catheters in 
Infants and Children,'' Clinical Journal of the American Society of 
Nephrology, vol. 6, pp. 793-798, 2011.
16. Draft guidance entitled ``Implanted Blood Access Devices for 
Hemodialysis,'' available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR Part 876 be amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for 21 CFR Part 876 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Section 876.5540 is amended by revising paragraphs (a)(1), (b)(1), 
and by removing paragraph (c) to read as follows:

Sec.  876.5540  Blood access device and accessories.

    (a) * * *
    (1) The implanted blood access device is a prescription device and 
consists of various flexible or rigid tubes, such as catheters, or 
cannulae, 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: Single, double, 
and triple lumen catheters with cuffs; subcutaneous ports with 
catheters; shunts; cannula; vessel tips; and connectors specifically 
designed to provide access to blood.
* * * * *
    (b) Classification. (1) Class II (special controls) for the 
implanted blood access device. The special controls for this device 
are:
    (i) Components of the device that come into human contact must be 
demonstrated to be biocompatible. Material names and specific 
designation numbers must be provided.
    (ii) Performance data must demonstrate that the device performs as 
intended under anticipated conditions of use. The following performance 
characteristics must be tested:
    (A) Pressure versus flow rates for both arterial and venous lumens, 
from the minimum flow rate to the maximum flow rate in 100 ml/min 
increments, must be established. The fluid and its viscosity used 
during testing must be stated.
    (B) Recirculation rates for both forward and reverse flow 
configurations must be established, along with the protocol used to 
perform the assay, which must be provided.
    (C) Priming volumes must be established.
    (D) Tensile testing of joints and materials must be conducted. The 
minimum acceptance criteria must be adequate for its intended use.
    (E) Air leakage testing and liquid leakage testing must be 
conducted.
    (F) Testing of the repeated clamping of the extensions of the 
catheter that simulates use over the life of the catheter must be 
conducted, and retested for leakage.

[[Page 38872]]

    (G) Mechanical hemolysis testing must be conducted.
    (H) Chemical tolerance of the catheter to repeated exposure to 
commonly used disinfection agents must be established.
    (iii) Performance data must demonstrate the sterility of the 
device.
    (iv) Performance data must support the shelf life of the device for 
continued sterility, package integrity, and functionality over the 
requested shelf life that must include tensile, repeated clamping, and 
leakage testing.
    (v) Labeling must bear all information required for the safe and 
effective use of implanted blood access devices for hemodialysis 
including the following:
    (A) Labeling must provide arterial and venous pressure versus flow 
rates, either in tabular or graphical format.
    (B) Labeling must provide the arterial and venous priming volumes.
    (C) Labeling must specify the forward and reverse recirculation 
rates.
    (D) Labeling must specify an expiration date.
    (E) Labeling must identify any disinfecting agents that cannot be 
used to clean any components of the device.
    (F) Any contraindicated disinfecting agents due to material 
incompatibility must be identified by printing a warning on the 
catheter. Alternatively a label can be provided that can be affixed to 
the patient's medical record with this information.
    (G) The labeling must contain the following information: 
Comprehensive instructions for the preparation and insertion of the 
hemodialysis catheter, including recommended site of insertion, method 
of insertion, a reference on the proper location for tip placement, a 
method for removal of the catheter, anticoagulation, guidance for 
management of obstruction and thrombus formation, and site care.
    (H) The labeling must identify any coatings or additives and 
summarize the results of performance testing for any coating or 
material with special characteristics, such as decreased thrombus 
formation or antimicrobial properties.
    (vi) For subcutaneous devices, the recommended type of needle for 
access must be described, stated in the labeling, and test results on 
repeated use of the ports must be provided.
    (vii) Coated devices must include a description of the coating or 
additive material, duration of effectiveness, how the coating is 
applied, and testing to adequately demonstrate the performance of the 
coating.
* * * * *

    Dated: June 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15504 Filed 6-27-13; 8:45 am]
BILLING CODE 4160-01-P