Document ID: FDA-2012-N-0303-0005
Agency: fda
Document Type: Rule
Title: Medical Devices: Gastroenterology-Urology Devices; Implanted Blood Access Devices; Reclassification
Posted Date: 2014-07-25T04:00Z

[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Rules and Regulations]
[Pages 43241-43246]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17477]

[[Page 43241]]

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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: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final 
order to reclassify implanted blood access devices, a preamendments 
class III device, into class II (special controls) based on new 
information and subject to premarket notification and to further 
clarify the identification.

DATES: This order is effective July 25, 2014.

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, 
rebecca.nipper@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended 
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the 
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 
105-115), the Medical Device User Fee and Modernization Act of 2002 
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. 
L. 108-214), the Food and Drug Administration Amendments Act of 2007 
(Pub. L. 110-85), and the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (Pub. L. 112-144), 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(d) 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, FDASIA was enacted. Section 608(a) of FDASIA 
amended section 513(e) of the FD&C Act, changing the mechanism for 
reclassifying a device from rulemaking to an administrative order.
    Section 513(e) of the FD&C Act governs reclassification of 
classified preamendments devices. This section 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 
Department of Health, Education, and 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 action where the reevaluation is made 
in light of newly available authority (see Bell, 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'' (Upjohn, 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 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. 
FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Manufacturers 
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 
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 to a public docket. FDA published a 
proposed order to reclassify this device in the Federal Register of 
June 28, 2013 (78 FR 38867). FDA received and has considered one 
comment on this proposed order, as discussed in section II. FDA has 
held a meeting of a device classification panel described in section 
513(b) of the FD&C Act with respect to implanted blood access devices, 
and therefore, has met this requirement under section 513(e)(1) of the 
FD&C Act. As explained further in section III, a meeting of a device 
classification panel described in section 513(b) of the FD&C Act, the 
Gastroenterology and Urology Devices Panel of the Medical Devices 
Advisory Committee (the Panel), took place on June 27, 2013 (78 FR 
25747, May 2,

[[Page 43242]]

2013), to discuss whether implanted blood access devices should be 
reclassified or remain in class III. The reclassification of implanted 
blood access devices was mostly supported by the Panel. During 
deliberations, the Panel recommended that implanted hemodialysis 
catheters and implanted coated hemodialysis catheters be reclassified 
into class II because there was sufficient information to establish 
special controls, with the provision of slight modifications to the 
risks to health, as well as the proposed special controls. The majority 
of the Panel members expressed concern that the risks associated with 
the fully subcutaneous implanted blood access devices (port-catheter 
systems or fully subcutaneous port-catheter systems) or the 
arteriovenous (A-V) shunt cannulae might not be mitigated by the 
proposed special controls and recommended that these two implanted 
blood access device subtypes remain in class III. Details of the 
Panel's recommendations and FDA's response are provided in section III.
    FDA is not aware of new information since the Panel meeting that 
would provide a basis for a different recommendation or findings.

II. Public Comments in Response to the Proposed Order

    In response to the June 28, 2013, proposed order to reclassify 
implanted blood access devices, FDA did not receive any comments. 
However, in response to the draft guidance that published the same day 
(78 FR 38994, June 28, 2013) FDA received one comment. The comment 
included suggestions for revision to the proposed special controls, and 
is therefore relevant to the proposed order. In general, the comment 
supported FDA's intent to reclassify implanted blood access devices 
including the implementation of special controls. Regarding the special 
controls, the commenter recommended that the special control relating 
to mechanical hemolysis be modified to specify that it only applies to 
devices that include a new or altered blood flow pattern. They also 
recommended that chemical tolerance testing only be necessary for the 
disinfection agents listed within the product labeling, and not to all 
``commonly used disinfection agents,'' and that the compatible agents 
must be listed in the labeling, as opposed to a listing of the 
disinfecting agents that cannot be used. Finally, in relation to 
disinfecting agents, the commenter suggested that the term 
``contraindicated'' be avoided and suggested alternative language 
regarding providing appropriate information to users regarding 
incompatible disinfecting agents. It was also recommended that the 
special control relating to sterility be modified to specify that not 
only the package remain sterile, but also its contents.
    FDA continues to believe that the proposed special controls 
(section VIII of the proposed order), with minor modifications as 
discussed in section III, provide a reasonable assurance of safety and 
effectiveness. Although the Panel did not comment specifically on any 
of the revisions recommended by the commenter, FDA considered the 
suggestions and adopted the recommendations regarding mechanical 
hemolysis testing, as reflected in the revised special control.
    Regarding the comments relating to the testing and labeling of 
compatible cleaning and disinfecting agents, FDA agrees that an 
alternative to printing contraindicated disinfecting agents directly on 
the catheter would be to provide the information on both the patient's 
medical record and directly to the patient via an implant card. The 
associated special control has been modified from that proposed only to 
specifically state that a patient implant card must be provided, which 
was not previously stated. FDA disagrees, however, with the other 
comments regarding disinfecting agents, and believes that in order to 
reasonably assure the safety and effectiveness of implanted blood 
access devices, due to the variation in facility protocols regarding 
care and maintenance of this device type, chemical tolerance to or 
incompatibility with commonly used disinfection agents must be 
established. It is insufficient to only conduct chemical tolerance 
testing for the compatible disinfection agents listed within the 
product labeling. Therefore, the related special control regarding the 
requirement to establish the device's chemical tolerance to repeated 
exposure to commonly used disinfection agents remains unchanged. FDA 
believes that the requirement that the device remain sterile in 
addition to the packaging has been adequately captured in the proposed 
special control, and therefore no associated changes were made.
    FDA believes that the special controls provide a reasonable 
assurance of safety and effectiveness for implanted blood access 
devices that feature similar technology and indications. The Agency 
believes it has now identified all relevant risks to health (see 
section V of the proposed order for the originally identified risks to 
health and section III of this document for updated risks to health 
based on Panel recommendations) and that the mitigation methods 
described in the associated special controls will be effective in 
mitigating these risks. These risks and mitigations were based on 
recommendations from the June 27, 2013, Gastroenterology and Urology 
Devices Panel of the Medical Devices Advisory Committee (Ref. 1) as 
further described in section III; the information gathered from the 
Manufacturer and User Facility Device Experience database and FDA's 
literature review (see FDA's Executive Panel Summary, Ref. 2); and 
information provided in response to the proposed order.

III. Deliberations of the Panel

    In Session II of the June 27, 2013, device classification panel 
meeting, the Panel considered the reclassification of implanted blood 
access devices (Ref. 1) from class III to class II (special controls). 
The Panel was asked to provide input on the risks to health, safety, 
and effectiveness of these devices.
    The reclassification of implanted blood access devices was 
partially supported by the Panel. During deliberations, the Panel 
concluded that it would be acceptable to reclassify the implanted 
hemodialysis catheters and the implanted coated hemodialysis catheters 
into class II with slight modifications to the risks to health as well 
as the proposed special controls, as discussed further in this 
document. However, the Panel expressed concern that the proposed 
special controls may not be adequate to mitigate the risks associated 
with the fully subcutaneous port-catheter systems or the A-V shunt 
cannulae and, as a result of this concern over the ability to establish 
adequate special controls, recommended that these two implanted blood 
access device subtypes remain in class III. The concern for the fully 
subcutaneous port-catheter devices was based on a higher risk of 
infectious complications historically noted for these devices compared 
with other types of implanted blood access devices for hemodialysis. 
Because the A-V shunt cannulae access the arterial circulation, the 
Panel expressed concerns that the risks of arterial thrombosis, 
premature separation, severe bleeding, air embolism, and steal syndrome 
might not be mitigated by the proposed special controls.
    FDA does not agree with the Panel that these two device subtypes 
should remain in class III. To address the concerns expressed by the 
Panel, FDA has modified the special controls by including additional 
special controls that will require the submission of

[[Page 43243]]

clinical performance data for these two device subtypes. Of note, 
arteriovenous grafts (vascular graft prostheses), another type of 
implanted vascular access for hemodialysis, are similar to A-V shunt 
cannulae in that they also access the arterial circulation. These 
devices are currently regulated as class II medical devices (21 CFR 
870.3450). A-V shunt cannulae are unique in that they have an external 
component, but FDA believes the overall categories of risk are similar. 
Fully subcutaneous port-catheter systems indicated for infusion, which 
have similar design features and a similar risk profile to the fully 
subcutaneous port-catheter systems indicated for hemodialysis, are 
currently also regulated as class II medical devices (21 CFR 880.5965). 
Based on reported adverse events and device recalls, and on the lack of 
increased infection being noted in current practice guidelines for 
these devices, FDA believes that arteriovenous grafts and fully 
subcutaneous port-catheter systems indicated for infusion are 
adequately regulated as class II devices. Given that devices with 
similar risk profiles, indications, and technologies are currently 
regulated as class II medical devices, FDA believes that special 
controls can be established for fully subcutaneous port-catheter 
devices and A-V shunt cannulae to mitigate the identified risks to 
health and provide a reasonable assurance of safety and effectiveness.
    FDA presented the risks to health to the Panel, and the Panel fully 
supported the risks as originally identified, and provided the 
following additional comments. Several Panel members felt that the 
risks of arterial thrombosis (in addition to venous thrombosis), 
premature separation and bleeding, potential for exsanguination, air 
embolism, and steal syndrome should be included for A-V shunt cannulae. 
With the exception of steal syndrome, FDA believes that these risks 
were already included, but appreciates the Panel input with regard to 
the increased risks of thrombosis, bleeding, and air embolism when the 
devices are inserted into the arterial circulation. Clarifying comments 
have been added to the previously identified risks, and a new risk was 
added for vascular access steal syndrome. The Panel also felt that the 
risk of ``Infection and pyrogen reactions'' should be expanded to state 
that improper insertion, care, or maintenance of the device can also 
lead to infection. As a result, FDA has added clarifying statements to 
this previously identified risk to health. Similarly, the Panel members 
felt that the risk of anaphylaxis should be included as a risk for 
coated devices. FDA does not believe that this is a newly identified 
risk and has now included clarifying statements to include this risk 
subtype under the category of ``Adverse tissue reaction'' as well as 
additional language regarding the risks specific to coated devices. 
Clarifying statements have also been added to the category of ``Device 
Failure'' specifically relating the risk to coated devices in addition 
to non-coated devices.
    Based upon the Panel's input as described and FDA's review, FDA has 
updated the risks to the following:
     Thrombosis in patient, device 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. If the device accesses the arterial circulation, the 
device could cause arterial stenosis or thrombosis.
     Adverse tissue reaction: Inadequate tissue compatibility 
of the materials used in this device, including coatings or additives, 
could cause an immune reaction. This could include anaphylaxis for 
coated devices.
     Infection and pyrogen reactions: Skin or bloodstream 
infections could result from an improperly sterilized device, 
inappropriate preparation of the insertion site, or improper care and 
maintenance of the device exit site.
     Device failure: Weakness of connections or materials 
(including coatings or additives) could lead to breakage, which could 
result in 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, such as vessel 
perforation. Inappropriate placement or removal of the device could 
cause air embolism or hemorrhage.
     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 device migration: The cuff of 
implanted devices may not allow adequate ingrowth from the surrounding 
subcutaneous tissue, which could cause the device to dislodge or fall 
out with subsequent blood loss. If the device accesses the arterial 
circulation, inadvertent separation could result in severe hemorrhage 
including exsanguination.
     Vascular access steal syndrome associated with devices 
inserted into the artery and vein: Alterations in blood flow paths 
could result if the device accesses both the arterial and venous 
circulation, which could result in decreased blood flow to the distal 
extremity.
    The Panel agreed that general controls were not sufficient to 
provide a reasonable assurance of safety and effectiveness, and also 
that these devices are life-supporting or life-sustaining. The Panel 
mostly agreed that FDA's list of special controls from the June 28, 
2013, proposed order would mitigate the identified risks and provide 
reasonable assurance of safety and effectiveness for the implanted 
hemodialysis catheters and the implanted coated hemodialysis catheters. 
Some of the panelists expressed concerns regarding the specificity of 
some of the proposed special controls and suggested modifications. As 
described further in this document, FDA largely agreed with the special 
control recommendations and has revised the special controls 
accordingly (see section IV. The Final Order). The special controls 
were also modified in response to the modifications to the risks to 
health previously described.
    The Panel recommended updating the special control for labeling to 
include proper care and maintenance of the device and device exit-site 
and to specify appropriate qualifications for clinical providers 
performing the insertion, maintenance, and removal of the devices. FDA 
agreed with this recommendation. In response to the Panel's recommended 
modifications to the risks to health, a special control for labeling 
was also added for coated devices to include a Warning Statement for 
potential allergic reactions including anaphylaxis if the coating or 
additive contains known allergens. FDA also added labeling special 
controls for A-V shunt cannulae to include Warning Statements for 
vascular access steal syndrome, arterial stenosis, arterial thrombosis, 
and hemorrhage including exsanguination given that the device accesses 
the arterial circulation.
    FDA added new special controls requiring clinical performance data 
for the fully subcutaneous port-catheter devices and the A-V shunt 
cannulae in order to address the Panel concerns for a higher risk of 
infectious complications historically noted for the fully subcutaneous 
devices and the risks of arterial thrombosis, premature separation, 
severe bleeding, air embolism, and steal syndrome for the A-V shunt 
cannulae. FDA believes that

[[Page 43244]]

clinical performance data could adequately characterize adverse events 
observed during clinical use in the intended population in order to 
inform FDA and therefore provide a reasonable assurance of safety and 
effectiveness.
    Table 1 shows how FDA believes that the risks to health identified 
and listed in this document can be mitigated by the special controls.

Table 1--Health Risks and Mitigation Measures for Implanted Blood Access
                                 Devices
------------------------------------------------------------------------
          Identified risk                    Mitigation measures
------------------------------------------------------------------------
Thrombosis in patient and catheter  Performance testing.
                                    Labeling.
                                    Sterility.
                                    Clinical performance testing
                                     (devices inserted into artery,
                                     e.g., A-V shunt cannulae).
Adverse tissue reaction...........  Biocompatibility.
                                    Sterility.
                                    Expiration date testing.
                                    Labeling (with inclusion of Warning
                                     Statement for anaphylaxis for
                                     devices with coatings or
                                     additives).
                                    Materials characterization (devices
                                     with coatings or additives).
Infection and pyrogen reactions...  Performance testing.
                                    Clinical performance testing (fully
                                     subcutaneous port-catheter
                                     devices).
                                    Sterility.
                                    Expiration date testing.
                                    Labeling.
Device failure....................  Performance testing.
                                    Expiration date testing.
                                    Labeling.
Cardiac arrhythmia, hemorrhage,     Performance testing.
 embolism, nerve injury, or vessel
 perforation.
                                    Labeling.
                                    Clinical performance testing
                                     (devices inserted into artery,
                                     e.g., A-V shunt cannulae).
Hemolysis.........................  Performance testing.
                                    Labeling.
Accidental withdrawal or device     Biocompatibility.
 migration.
                                    Performance testing.
                                    Clinical performance testing
                                     (devices inserted into artery,
                                     e.g., A-V shunt cannulae).
                                    Labeling.
Vascular access steal syndrome      Labeling.
 associated with devices inserted   Clinical performance testing
 into the artery and vein.           (devices inserted into artery,
                                     e.g., A-V shunt cannulae).
------------------------------------------------------------------------

IV. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings, 
as published in the preamble to the June 28, 2013, proposed order. FDA 
has made revisions in this final order in response to the comments 
received (see section II) and the deliberations of the Panel (see 
section III). As published in the proposed order, FDA is issuing this 
final order to reclassify implanted blood access devices from class III 
to class II and establish special controls by revising Sec.  876.5540 
(21 CFR 876.5540). The identification for Sec.  876.5540(a)(1) has been 
revised to provide a more accurate description of devices in this 
classification regulation.
    In response to the input of the Panel, FDA also made refinements to 
the proposed special controls as described previously. FDA added new 
special controls requiring clinical performance data for the fully 
subcutaneous port-catheter devices and the A-V shunt cannulae. 
Additionally, FDA updated the special controls for labeling and updated 
special controls for implanted blood access devices with coatings.
    Following the effective date of this final order, firms submitting 
a premarket notification (510(k)) for an implanted blood access device 
will need either to (1) comply with the particular mitigation measures 
set forth in the codified special controls or (2) use alternative 
mitigation measures, but demonstrate to the Agency's satisfaction that 
those alternative measures identified by the firm will provide at least 
an equivalent assurance of safety and effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act if FDA determines that premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the devices. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of safety and 
effectiveness of implanted blood access devices, and therefore, this 
device type is not exempt from premarket notification requirements.

V. 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.

VI. Paperwork Reduction Act of 1995

    This final order refers to previously 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 21 CFR part 812 have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
part 807, subpart E, have been approved under OMB control number 0910-
0120; and the collections of information under 21 CFR part 801 have 
been approved under OMB control number 0910-0485.

[[Page 43245]]

VII. 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. Changes resulting from final orders will appear in the CFR 
as changes to codified classification determinations or as newly 
codified orders. Therefore, under section 513(e)(1)(A)(i), as amended 
by FDASIA, in this final order, we are revoking the requirements in 
Sec.  876.5540(b)(1) related to the classification of implanted blood 
access devices as class III devices and codifying the reclassification 
of implanted blood access devices into class II (special controls).

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 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. (FDA 
has verified all the Web site addresses in this reference section, but 
we are not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)
1. Transcript of the June 27, 2013, meeting of the Gastroenterology 
and Urology Devices Panel (available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM362271.pdf).
2. FDA Executive Summary prepared for the June 27, 2013, meeting of 
the Gastroenterology and Urology Devices Panel (available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM358369.pdf).

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, 21 CFR part 
876 is 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. Amend Sec.  876.5540 by revising paragraphs (a)(1) and (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 various 
catheters, shunts, and connectors specifically designed to provide 
access to blood. Examples include single and double lumen catheters 
with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt 
cannulae (with vessel tips). The implanted blood access device may also 
contain coatings or additives which may provide additional 
functionality to the device.
* * * * *
    (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 milliliter 
per minute 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 device must be 
conducted, and retested for leakage.
    (G) Mechanical hemolysis testing must be conducted for new or 
altered device designs that affect the blood flow pattern.
    (H) Chemical tolerance of the device 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 of implanted blood access devices for hemodialysis 
must include the following:
    (A) Labeling must provide arterial and venous pressure versus flow 
rates, either in tabular or graphical format. The fluid and its 
viscosity used during testing must be stated.
    (B) Labeling must specify the forward and reverse recirculation 
rates.
    (C) Labeling must provide the arterial and venous priming volumes.
    (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, contraindicated disinfecting agents must be 
identified by a label affixed to the patient's medical record and with 
written instructions provided directly to the patient.
    (G) Labeling must include a patient implant card.
    (H) The labeling must contain comprehensive instructions for the 
following:
    (1) Preparation and insertion of the device, including recommended 
site of insertion, method of insertion, and a reference on the proper 
location for tip placement;
    (2) Proper care and maintenance of the device and device exit site;
    (3) Removal of the device;
    (4) Anticoagulation;
    (5) Management of obstruction and thrombus formation; and
    (6) Qualifications for clinical providers performing the insertion, 
maintenance, and removal of the devices.
    (vi) In addition to Special Controls in paragraphs (b)(1)(i) 
through (v) of this section, implanted blood access devices

[[Page 43246]]

that include subcutaneous ports must include the following:
    (A) Labeling must include the recommended type of needle for access 
as well as detailed instructions for care and maintenance of the port, 
subcutaneous pocket, and skin overlying the port.
    (B) Performance testing must include results on repeated use of the 
ports that simulates use over the intended life of the device.
    (C) Clinical performance testing must demonstrate safe and 
effective use and capture any adverse events observed during clinical 
use.
    (vii) In addition to Special Controls in paragraphs (b)(1)(i) 
through (v) of this section, implanted blood access devices with 
coatings or additives must include the following:
    (A) A description and material characterization of the coating or 
additive material, the purpose of the coating or additive, duration of 
effectiveness, and how and where the coating is applied.
    (B) An identification in the labeling of any coatings or additives 
and a summary of the results of performance testing for any coating or 
material with special characteristics, such as decreased thrombus 
formation or antimicrobial properties.
    (C) A Warning Statement in the labeling for potential allergic 
reactions including anaphylaxis if the coating or additive contains 
known allergens.
    (D) Performance data must demonstrate efficacy of the coating or 
additive and the duration of effectiveness.
    (viii) The following must be included for A-V shunt cannulae (with 
vessel tips):
    (A) The device must comply with Special Controls in paragraphs 
(b)(1)(i) through (v) of this section with the exception of paragraphs 
(b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do 
not apply.
    (B) Labeling must include Warning Statements to address the 
potential for vascular access steal syndrome, arterial stenosis, 
arterial thrombosis, and hemorrhage including exsanguination given that 
the device accesses the arterial circulation.
    (C) Clinical performance testing must demonstrate safe and 
effective use and capture any adverse events observed during clinical 
use.
    (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.

    Dated: July 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17477 Filed 7-24-14; 8:45 am]
BILLING CODE 4164-01-P