[Federal Register Volume 78, Number 125 (Friday, June 28, 2013)]
[Notices]
[Pages 38994-38995]
From the Federal Register Online via the Government Publishing 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Implanted Blood Access Devices for Hemodialysis; Draft Guidance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availability of the draft guidance entitled ``Implanted Blood Access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 This draft guidance is not final nor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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 27, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Implanted Blood Access Devices for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Submit electronic comments on the draft guidance to http://www.regulations.gov.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This draft guidance document is being issued in conjunction with a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 [email protected] 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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