
[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 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 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]
 BILLING CODE 4164-01-P


