Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices, 36951-36955 [2012-15024]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Proposed Rules]
[Pages 36951-36955]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15024]


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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 rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify the implanted blood access device preamendments class III 
device into class II (special controls). FDA is proposing this 
reclassification on its own initiative based on new information. FDA is 
taking this action under the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act), as amended by the Medical Device Amendments of 1976 (the 
1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food 
and Drug Administration Modernization Act of 1997 (FDAMA), and the 
Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

DATES: Submit either electronic or written comments on the proposed 
rule by September 18, 2012. Please see section XIII of this document 
for the effective date of any final rule that may publish based on this 
proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0303 by any of the following methods, except that comments on 
information collection issues under the Paperwork Reduction Act of 1995 
must be submitted to the Office of Regulatory Affairs, Office of 
Management and Budget (OMB) (see the ``Paperwork Reduction Act of 
1995'' section of this document).

Electronic Submissions

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

Written Submissions

    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, 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 number for this rulemaking. All comments received may be 
posted without change to https://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 https://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: Jeffrey Cooper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. G228, Silver Spring, MD 20993, 301-796-6517.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The FD&C Act, as amended by the 1976 amendments (Pub. L. 94-295), 
the SMDA (Pub. L. 101-629), the FDAMA

[[Page 36952]]

(Pub. L. 105-115), the MDUFMA (Pub. L. 107-250), the Medical Devices 
Technical Corrections Act (Pub. L. 108-214), and the Food and Drug 
Administration Amendments Act of 2007 (Pub. L. 110-85), establish 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).
    A preamendments device that has been classified into class III may 
be marketed by means of premarket notification procedures (510(k) 
process) without submission of a premarket approval application (PMA) 
until FDA issues a final regulation under section 515(b) of the FD&C 
Act (21 U.S.C. 360e(b)) requiring premarket approval.
    Section 513(e) of the FD&C Act governs reclassification of 
classified preamendments devices. This section provides that FDA may, 
by rulemaking, reclassify a device (in a proceeding that parallels the 
initial classification proceeding) based upon ``new information.'' FDA 
can initiate a reclassification under section 513(e) of the FD&C Act 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 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 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, 389-391 (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 past 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 Assoc. v. FDA, 766 F.2d 592 
(D.C. Cir.), cert. denied, 474 U.S. 1062 (1985)).
    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 
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.
    FDAMA added a new section 510(m) to the FD&C Act. New 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

    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 if there are not adequate data to assure the safe and 
effective use of the device. 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.

III. Device Description

    Implanted blood access devices include various flexible or rigid 
tubes, such as catheters, cannulae or hollow needles. 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

[[Page 36953]]

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. AV 
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. They are similar to the subcutaneous 
catheters.

IV. Proposed Reclassification

    FDA is proposing that the device subject to this proposal be 
reclassified from class III to class II. FDA believes that the 
identified special controls would provide reasonable assurance of 
safety and effectiveness. Therefore, in accordance with sections 513(e) 
and 515(i) of the FD&C Act and 21 CFR 860.130, based on new information 
with respect to the devices, 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. FDA has considered 
implanted blood access devices in accordance with the reserved criteria 
and decided that the device does require premarket notification. The 
Agency does not intend to exempt this proposed class II device from 
premarket notification (510(k)) submission as provided for under 
section 510(m) of the FD&C Act.

V. Risks to Health

    After considering the information from the reports and 
recommendations of the advisory committees (panels) for the 
classification of these devices along with information submitted in 
response to the 515(i) order and any additional information that FDA 
has encountered, FDA has evaluated the risks to health associated with 
the use of implanted blood access devices and determined that the 
following risks to health are associated with its use:
    1. Thrombosis in patient and catheter. 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.
    2. Adverse tissue reaction. Inadequate tissue compatibility of the 
materials used in this device could cause an immune reaction.
    3. Infection and pyrogen reactions. An improperly sterilized device 
could cause an infection or an unclean device could cause a fever.
    4. Device failure. Weakness of connections or materials could lead 
to blood loss.
    5. Cardiac Arrhythmia, hemorrhage, embolism, nerve injury, or 
vessel perforation. Improper placement into the heart or blood vessel 
could damage tissues and result in injuries.
    6. Hemolysis. The destruction of red blood cells due to turbulence 
or high pressure created by narrow openings or changes in blood flow 
paths.

VI. Summary of Reasons for Reclassification

    FDA believes that implanted blood access devices should be 
reclassified into 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. In addition, there is now 
adequate effectiveness information sufficient to establish special 
controls to provide such assurance.

VII. Summary of Data Upon Which the Reclassification is Based

    Since 1987 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 known. 
The risks include clotting, infection, and breakage of the materials, 
and these risks can be adequately mitigated by special controls. 
Catheters continue to evolve over time with improved materials and 
insertion techniques. A review of 15 publications shows a decrease in 
infections and an increase in patency over three decades (1980 to 2010) 
(Refs. 2-16). FDA believes that special controls currently in use can 
ensure the safety and effectiveness of implanted blood access devices.

VIII. Proposed Special Controls-Related Documents

    FDA believes that the special controls as described in the guidance 
document ``Class II Special Controls Guidance Document: Implanted Blood 
Access Devices for Hemodialysis'' (Ref. (1) are sufficient to mitigate 
the risks to health described in section V of this document. Elsewhere 
in this issue of the Federal Register, FDA is announcing the 
availability of a draft guidance document that, when finalized, would 
serve as a special control, if FDA reclassifies this device. If 
adopted, following the effective date of a final rule classifying the 
device, any firm submitting a 510(k) premarket notification for the 
device would need to address the issues covered in the special control 
guidance. However, the firm would need to show only that its device 
meets the recommendations of the guidance or in some other way provides 
equivalent assurances of safety and effectiveness.

IX. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612) and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this proposed rule is not a 
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because reclassification of implanted blood access 
devices from class III to class II with special controls makes these 
devices' formal classification consistent with current FDA and industry 
practice, the Agency proposes to certify that the final rule will not 
have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation)

[[Page 36954]]

in any one year.'' The current threshold after adjustment for inflation 
is $136 million, using the most current (2010) Implicit Price Deflator 
for the Gross Domestic Product. FDA does not expect this proposed rule 
to result in any 1-year expenditure that would meet or exceed this 
amount.
    FDA is proposing to reclassify implanted blood access devices from 
class III to class II with special controls. Typically, a class III 
device must be granted premarket approval by FDA. However, at the 
present time, implanted blood access devices are handled in a fashion 
similar to class II devices, with manufacturers receiving clearance to 
market via a 510(k) and no PMA requirement. Hence, this rule brings the 
formal classification of implanted blood access devices into line with 
current practice and will likely cause little to no change in behavior 
on the part of industry, consumers, or FDA. There remains the 
possibility that some new actions will be required of industry in light 
of the formalization of class II special controls. To the extent that 
manufacturers are not already complying with the recommendations 
contained in the special controls guidance document, manufacturers will 
incur additional costs, which may then be passed on to consumers or 
insurance payers in the form of higher prices. We anticipate that such 
costs will be negligible, however, because the proposed special 
controls for labeling, safety, and performance testing reflect current 
FDA requirements for marketing clearance of implanted blood access 
devices.
    FDA has already recognized that the 510(k) premarket notification 
process is sufficient for ensuring the safety and effectiveness of 
these products. Firms have not been required to submit PMAs or meet 
other requirements typically expected of manufacturers of class III 
devices, and the Agency expects that continuing the current 510(k) 
clearance process will pose no new risks to consumers. FDA requests 
comment on this issue and on all costs and benefits of the proposed 
reclassification.

XI. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive order requires Agencies to ``construe * * * a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Federal law includes an express preemption 
provision that preempts certain state requirements ``different from or 
in addition to'' certain Federal requirements applicable to devices. 
(See section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic, Inc. v. 
Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, Inc. 128 S. Ct. 999 
(2008)). If this proposed rule is made final, the special controls 
established by the final rule would create ``requirements'' for 
specific medical devices under 21 U.S.C. 360(k), even though product 
sponsors have some flexibility in how they meet those requirements (Cf. 
Papike v. Tambrands, Inc., 107 F.3d 737, 740-742 (9th Cir. 1997)).

XII. Paperwork Reduction Act of 1995

    This proposed rule 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 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.

XIII. Proposed Effective Date

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

XIV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

XV. References

    The following reference has 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. (FDA has 
verified the Web site address, but we are not responsible for any 
subsequent changes to the Web site after this document publishes in the 
Federal Register.)

1. Draft guidance entitled ``Class II Special Controls Guidance 
Document: Implanted Blood Access Devices for Hemodialysis,'' 
available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
2. Eisenhauer ED, Derveloy RJ, Hastings PR: Prospective evaluation 
of central venous pressure (CVP) catheters in a large city-county 
hospital. Ann Surg 196:560-564, 1982.
3. Vanholder V, Hoenich N, Ringoir S: Morbidity and mortality of 
central venous catheter hemodialysis: a review of 10 years' 
experience. Nephron 47:274-279, 1987.
4. Almirall J, Gonzalez J, Rello J, Campistol JM, Montoliu J, Puig 
de la Bellacasa J, Revert L, Gatell JM: Infection of hemodialysis 
catheters: incidence and mechanisms. Am J Nephrol 9:454-459, 1989.
5. Boyle MJ, Gawley WF, Hickey DP, Drumm J, Murphy DM, Hanson JS, 
Glacken P: Experience using the Quinton Permcath for haemodialysis 
in the Irish Republic. Nephrol Dial Transplant 12:1934-1939, 1997.
6. Randolph AG, Cook DJ, Gonzales CA, Pribble CG: Ultrasound 
guidance for placement of central venous catheters: a meta-analysis 
of the literature. Crit Care Med 24:2053-2058, 1996.
7. Arnold WP: Improvement in hemodialysis vascular access outcomes 
in a dedicated access center. Semin Dial 13:359-363, 2000.
8. Wivell W, Bettmann MA, Baxter B, Langdon DR, Remilliard B, 
Chobanian M: Outcomes and performance of the Tesio twin catheter 
system placed for hemodialysis access. Radiology 221:697-703, 2001.
9. Lund GB, Trerotola SO, Scheel PF Jr, Savader SJ, Mitchell SE, 
Venbrux AC, Osterman FA Jr: Outcome of tunneled hemodialysis 
catheters placed by radiologists. Radiology 198:467-472, 1996.
10. Trerotola SO, Johnson MS, Harris VJ, Shah H, Ambrosius WT, 
McKusky MA, Kraus MA: Outcome of tunneled hemodialysis catheters 
placed via the right internal jugular vein by interventional 
radiologists. Radiology 203:489-495, 1997.
11. Prabhu PN, Kerns SR, Sabatelli FW, Hawkins IF, Ross EA: Long-
term performance and complications of the Tesio twin catheter system 
for hemodialysis access. Am J Kidney Dis 30:213-218, 1997.
12. Schnabel KJ, Simons ME, Zevallos GF, Pron GE, Fenton SS, 
Sniderman KW, Vanderburgh LC: Image-guided insertion of the Uldall 
tunneled hemodialysis catheter: technical success and clinical 
follow-up. J Vasc Interv Radiol 8:579-586, 1997.
13. Nassar GM, Ayus JC: Infectious complications of the hemodialysis

[[Page 36955]]

access. Kidney Int 60:1-13, 2001 (1990s data).
14. Power A, Singh SK, Ashby D, Cairns T, Taube D, Duncan N: Long-
term Tesio catheter access for hemodialysis can deliver high 
dialysis adequacy with low complication rates. J Vasc Interv Radiol 
22:631-637, 2011.
15. Duncan ND, Singh S, Cairns TD, Clark M, El-Tayar A, Griffith M, 
Hakim N, Hamady M, McLean AG, Papalois V, Palmer A, Taube D: Tesio-
Caths provide effective and safe long-term vascular access. Nephrol 
Dial Transplant 19:2816-2822, 2004.
16. Eisenstein I, Tarabeih M, Magen D, Pollack S, Kassis I, Ofer A, 
Engel A, Zelikovic I: Low infection rates and prolonged survival 
times of hemodialysis catheters in infants and children. Clin J Am 
Soc Nephrol 6:793-798, 2011.

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

    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.

    2. Section 876.5540 is amended by revising paragraphs (a)(1), 
(a)(2), 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 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.
    (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 (Sec. Sec.  870.3450 and 870.3460), and are intended to 
remain in the body for less than 30 days. This generic type of device 
includes noncuffed catheters, fistula needles, single dialysis needles 
(coaxial flow needle), and the single needle dialysis set (alternating 
flow needle).
* * * * *
    (b) Classification. (1) Class II (special controls) for the 
implanted blood access device. The special control for this device is 
FDA's ``Class II Special Controls Guidance Document: Implanted Blood 
Access Devices for Hemodialysis.''
* * * * *

    Dated: June 15, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-15024 Filed 6-19-12; 8:45 am]
BILLING CODE 4160-01-P