
[Federal Register Volume 78, Number 125 (Friday, June 28, 2013)]
[Notices]
[Pages 38994-38995]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15505]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0749]


Implanted Blood Access Devices for Hemodialysis; Draft Guidance 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Implanted Blood Access 
Devices for Hemodialysis.'' This guidance was developed to support the 
reclassification of the Implanted Blood Access Devices for Hemodialysis 
into class II (special controls). This draft guidance is not final nor 
is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 27, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Implanted Blood Access Devices for 
Hemodialysis'' to the Division of Small Manufacturers, International, 
and Consumer Assistance, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

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

    This draft guidance document is being issued in conjunction with a 
Federal Register notice announcing the proposal to reclassify this 
device type. This draft guidance provides recommendations to assist 
manufacturers in developing their premarket submissions of implanted 
blood access devices for hemodialysis regulated under Sec.  
876.5540(a)(1) (21 CFR 876.5540(a)(1) and FDA believes

[[Page 38995]]

that special controls, when combined with the general controls, will be 
sufficient to provide reasonable assurance of the safety and 
effectiveness of implanted blood access devices for hemodialysis. Thus, 
a manufacturer who intends to market a device of this generic type must 
(1) conform to the general controls of the Federal Food, Drug & 
Cosmetic Act (the FD&C Act), including the premarket notification 
requirements described in 21 CFR part 807 Subpart E, (2) address the 
special controls associated with implanted blood access devices for 
hemodialysis codified in the Code of Federal Regulations Sec.  
876.5540(b)(1), and (b)(3) obtain a substantial equivalence 
determination from FDA prior to marketing the device.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on implanted 
blood access devices for hemodialysis. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``implanted blood access devices for hemodialysis'' you may either send 
an email request to dsmica@fda.hhs.gov to receive an electronic copy of 
the document or send a fax request to 301-847-8149 to receive a hard 
copy. Please use the document number 1781 to identify the guidance you 
are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance 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 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; the collections of information in 21 CFR part 801 and 
809 have been approved under OMB control number 0910-0485; 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 
56.115 have been approved under OMB control number 0910-0130; and the 
collections of information in 21 CFR part 54 have been approved under 
OMB control number 0910-0396.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document 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.

    Dated: June 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15505 Filed 6-27-13; 8:45 am]
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