Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 2711-2712 [2015-00755]
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Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices
IV. Paperwork Reduction Act of 1995
Under the PRA (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Accessory Classification De Novo
Request—(OMB Control Number 0910–
NEW)
The draft guidance encourages
manufacturers and other parties to
utilize the process defined in section
513(f)(2) of the FD&C Act to request
risk-based classifications of new types
of accessories. This process provides a
pathway to class I or class II
classification for accessory devices for
which general controls, or general and
special controls, provide a reasonable
assurance of safety and effectiveness,
but for which there is no legally
marketed predicate device.
In accordance with section 513(f)(2) of
the FD&C Act, manufacturers and other
parties may submit a de novo requesting
FDA to make a classification
determination for the accessory device
according to the criteria in section
513(a)(1) of the FD&C Act. The de novo
must include a description of the device
and detailed information and reasons
for any recommended classification (see
section 513(f)(2)(A)(v) of the FD&C Act).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Accessory classification de novo request ............................
8
1
8
180
1,440
rljohnson on DSK3VPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents are medical device
manufacturers seeking to market device
accessories. Of the approximately 41 de
novo applications received per year,
only two have been associated with
accessories. With heightened awareness
of the availability of the de novo
pathway for accessories, we expect to
receive four to six additional accessories
applications per year. Therefore, we
estimate that we will receive
approximately eight accessory
classification de novo requests per year.
Based on estimates by FDA
administrative and technical staff who
are familiar with the proposed
submission process for accessory
classification requests and on our
burden estimate for a similar
information collection request (see ‘‘De
Novo Classification Process Evaluation
of Automatic Class III Designation; Draft
Guidance for Industry and Food and
Drug Administration Staff;
Availability,’’ 79 FR 47651 at 47653,
August 14, 2014), we estimate that the
submission process for each accessory
classification request will take
approximately 180 hours.
The draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR parts 801 and 809 have been
VerDate Sep<11>2014
14:47 Jan 16, 2015
Jkt 235001
approved under OMB control number
0910–0485; 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 814 have been approved under
OMB control number 0910–0231; and
the collections of information in 21 CFR
part 860, subpart C, have been approved
under OMB control number 0910–0138.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
www.regulations.gov.
Dated: January 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–00856 Filed 1–16–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2153]
Mitigating the Risk of CrossContamination From Valves and
Accessories Used for Irrigation
Through Flexible Gastrointestinal
Endoscopes; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Mitigating the Risk of CrossContamination From Valves and
Accessories Used for Irrigation Through
Flexible Gastrointestinal Endoscopes.’’
FDA has received reports of blood and
stool traveling through colonoscope
irrigation channels and into the water
bottle and tubing when the irrigation
channel did not have a backflowprevention mechanism in place. This
draft guidance document, when
finalized, will highlight the crosscontamination risk associated with
SUMMARY:
E:\FR\FM\20JAN1.SGM
20JAN1
2712
Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices
rljohnson on DSK3VPTVN1PROD with NOTICES
specific types of irrigation valves and
accessories when used with flexible
gastrointestinal endoscopes, clarify
terminology used to describe these
devices, and outline strategies to
mitigate the risk of cross-contamination
between patients. 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 of 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 April 20, 2015.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Mitigating the Risk
of Cross-Contamination From Valves
and Accessories Used for Irrigation
Through Flexible Gastrointestinal
Endoscopes’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
Submit electronic comments on the
draft guidance to https://
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 20993–0002, 301–796–6527.
SUPPLEMENTARY INFORMATION:
I. Background
During colonoscopy or
esophagogastroduodenoscopy,
clinicians often use a water bottle to
supply irrigation for the procedure.
Clinicians typically use a single water
bottle for multiple patients without
reprocessing the water bottle between
patients. This practice raises the risk of
cross-contamination between patients,
because the water bottle and associated
tubing/connectors can become
contaminated with blood or stool that
travels up through the endoscope
VerDate Sep<11>2014
14:47 Jan 16, 2015
Jkt 235001
channels and tubing (a phenomenon
referred to as ‘‘backflow’’). FDA has
received reports of backflow from
colonoscope irrigation channels into the
water bottle and tubing when the
irrigation channel did not have a
backflow-prevention mechanism in
place.
This draft guidance document, when
finalized, will: (1) Highlight the crosscontamination risk associated with
specific types of irrigation valves and
accessories when used with flexible
gastrointestinal endoscopes; (2) clarify
terminology used to describe these
devices; and (3) and outline strategies to
mitigate the risk of cross-contamination
between patients. These strategies will
include recommendations on device
design and appropriate labeling.
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 mitigating the risk of crosscontamination from valves and
accessories used for irrigation through
flexible gastrointestinal endoscopes. 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
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Mitigating the Risk of CrossContamination from Valves and
Accessories Used for Irrigation Through
Flexible Gastrointestinal Endoscopes’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 1400054 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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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; and
the collections of information in 21 CFR
part 801 and 809 have been approved
under OMB control number 0910–0485.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://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 https://
www.regulations.gov.
Dated: January 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–00755 Filed 1–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1039]
General Wellness: Policy for Low Risk
Devices; Draft Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘General Wellness: Policy for
Low Risk Devices.’’ FDA is issuing this
draft guidance to provide clarity to
industry and FDA staff on the Center for
Devices and Radiological Health’s
(CDRH’s) compliance policy for low risk
products that promote a healthy lifestyle
(general wellness products). 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
SUMMARY:
E:\FR\FM\20JAN1.SGM
20JAN1
]]>Agencies
[Federal Register Volume 80, Number 12 (Tuesday, January 20, 2015)]
[Notices]
[Pages 2711-2712]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00755]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-2153]
Mitigating the Risk of Cross-Contamination From Valves and
Accessories Used for Irrigation Through Flexible Gastrointestinal
Endoscopes; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Mitigating the Risk of
Cross-Contamination From Valves and Accessories Used for Irrigation
Through Flexible Gastrointestinal Endoscopes.'' FDA has received
reports of blood and stool traveling through colonoscope irrigation
channels and into the water bottle and tubing when the irrigation
channel did not have a backflow-prevention mechanism in place. This
draft guidance document, when finalized, will highlight the cross-
contamination risk associated with
[[Page 2712]]
specific types of irrigation valves and accessories when used with
flexible gastrointestinal endoscopes, clarify terminology used to
describe these devices, and outline strategies to mitigate the risk of
cross-contamination between patients. 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 of 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 April 20, 2015.
ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Mitigating the Risk of Cross-Contamination From Valves and
Accessories Used for Irrigation Through Flexible Gastrointestinal
Endoscopes'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.
Submit electronic comments on the draft guidance to https://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 20993-0002, 301-796-6527.
SUPPLEMENTARY INFORMATION:
I. Background
During colonoscopy or esophagogastroduodenoscopy, clinicians often
use a water bottle to supply irrigation for the procedure. Clinicians
typically use a single water bottle for multiple patients without
reprocessing the water bottle between patients. This practice raises
the risk of cross-contamination between patients, because the water
bottle and associated tubing/connectors can become contaminated with
blood or stool that travels up through the endoscope channels and
tubing (a phenomenon referred to as ``backflow''). FDA has received
reports of backflow from colonoscope irrigation channels into the water
bottle and tubing when the irrigation channel did not have a backflow-
prevention mechanism in place.
This draft guidance document, when finalized, will: (1) Highlight
the cross-contamination risk associated with specific types of
irrigation valves and accessories when used with flexible
gastrointestinal endoscopes; (2) clarify terminology used to describe
these devices; and (3) and outline strategies to mitigate the risk of
cross-contamination between patients. These strategies will include
recommendations on device design and appropriate labeling.
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 mitigating
the risk of cross-contamination from valves and accessories used for
irrigation through flexible gastrointestinal endoscopes. 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 downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Mitigating the Risk of
Cross-Contamination from Valves and Accessories Used for Irrigation
Through Flexible Gastrointestinal Endoscopes'' may send an email
request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of
the document. Please use the document number 1400054 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; and the collections of information in 21 CFR part 801
and 809 have been approved under OMB control number 0910-0485.
V. Comments
Interested persons may submit either electronic comments regarding
this document to https://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 https://www.regulations.gov.
Dated: January 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00755 Filed 1-16-15; 8:45 am]
BILLING CODE 4164-01-P
