[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Notices]
[Pages 85967-85968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28604]
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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; Guidance for Industry and Food and Drug Administration
Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Mitigating the Risk of
Cross-Contamination From Valves and Accessories Used for Irrigation
Through Flexible Gastrointestinal Endoscopes.'' Flexible
gastrointestinal endoscopes and accessories are class II devices and
identified with product codes such as FDF, FDS, and OCX. When using
these devices during an entire day of procedures (e.g., colonoscopies),
clinicians typically use one irrigation system (i.e., one water bottle,
one set of tubing and valves, etc.) without cleaning and sterilizing
all the system components between patients. This guidance highlights
the cross-contamination risk associated with day-use of irrigation
systems used with flexible gastrointestinal endoscopes; clarifies
terminology used to describe these devices; and outlines strategies to
mitigate the risk of cross-contamination between patients during these
procedures.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-D-2153 for ``Mitigating the Risk of Cross-Contamination From
Valves and Accessories Used for Irrigation Through Flexible
Gastrointestinal Endoscopes.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be
[[Page 85968]]
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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.
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 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.
FOR FURTHER INFORMATION CONTACT: Shanil Haugen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G104, Silver Spring, MD 20993-0002, 301-796-0301.
SUPPLEMENTARY INFORMATION:
I. Background
Flexible gastrointestinal endoscopes and accessories (including
valves and other devices used for irrigation) are class II devices
regulated under 21 CFR 876.1500, Endoscope and accessories. During a
colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use
an irrigation system comprised of a water bottle, tubing, valves, etc.,
to supply irrigation for the procedure. Clinicians typically do not
clean and sterilize all components of the irrigation system after each
procedure; e.g., they may use a single water bottle for an entire day
of procedures without reprocessing the water bottle between patients.
This practice raises the risk of cross-contamination between patients,
because the water bottle and associated tubing and connectors can
become contaminated with the fluids and materials (e.g., blood, stool)
of patients that travel back through the irrigation system channels and
tubing during the procedure.
FDA is providing this guidance to highlight the cross-contamination
risk posed by specific practices and types of irrigation valves and
accessories; clarify terminology used to describe irrigation system
components; and outline recommended mitigation strategies (e.g., device
design, labeling) meant to reduce the risk of cross-contamination
between patients from the day-use of irrigation system tubing, valves,
and accessories. FDA announced the availability of the draft guidance
in the Federal Register of January 20, 2015 (80 FR 2711). Interested
persons were invited to comment by April 20, 2015, and the final
guidance includes revisions intended to address the comments received.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Mitigating the Risk of Cross-Contamination
From Valves and Accessories Used for Irrigation Through Flexible
Gastrointestinal Endoscopes. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the 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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://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 [email protected] 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 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
have been approved under OMB control number 0910-0485.
Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28604 Filed 11-28-16; 8:45 am]
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