[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72976-72978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27823]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5606]


Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use--
Premarket Notification (510(k)) Submissions; 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 a final guidance entitled ``Arthroscopy Pump Tubing 
Sets Intended for Multiple Patient Use--Premarket Notification (510(k)) 
Submissions.'' FDA has developed this guidance document to assist in 
the preparation of premarket notification submissions (510(k)) for 
arthroscopy pump tubing sets intended for multiple patient use. This 
guidance outlines the device design considerations, risk mitigation 
strategies, and testing recommendations for arthroscopy pump tubing 
sets intended for multiple patient use. This guidance also clarifies 
the terminology used to describe arthroscopy pump tubing sets intended 
for multiple patient use.

DATES: The announcement of the guidance is published in the Federal 
Register on December 23, 2021.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and

[[Page 72977]]

identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-5606 for ``Arthroscopy Pump Tubing Sets Intended for 
Multiple Patient Use--Premarket Notification (510(k)) Submissions.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 
``Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use--
Premarket Notification (510(k)) Submissions'' to the Office of Policy, 
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: Laurence Coyne, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4512, Silver Spring, MD 20993-0002, 301-796-6450.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Arthroscopy Pump Tubing Sets Intended for Multiple 
Patient Use--Premarket Notification (510(k)) Submissions.'' FDA has 
developed this guidance document to assist in the preparation of 
premarket notification submissions (510(k)) for arthroscopy pump tubing 
sets intended for multiple patient use. These devices are designed to 
deliver irrigation fluid to the surgical site, such as knee, shoulder, 
hip, elbow, ankle, and wrist joint cavities, during arthroscopic 
procedures. In arthroscopic procedures, clinicians often use a single 
source of irrigation fluid for multiple patients without replacing the 
source of irrigation fluid or replacing/reprocessing the irrigation 
tubing system between patients. This practice may increase the risk of 
cross-contamination between patients and subsequent iatrogenic 
infection because the irrigation system can become contaminated with 
patient fluids that travel back through the irrigation tubing 
(``backflow''). FDA has received reports of backflow of patient fluids 
which raises the question of potential for disease transmission when 
using irrigation and tubing systems in such a manner on multiple 
patients.
    This guidance is intended to provide recommendations for 
information to include in premarket notifications (510(k)s) for 
arthroscopy pump tubing sets intended for multiple patient use. This 
guidance outlines device design considerations, risk mitigation 
strategies, and testing recommendations for these devices, and 
clarifies the terminology used to describe arthroscopy pump tubing sets 
intended for multiple patient use.
    A notice of availability of the draft guidance appeared in the 
Federal Register of January 28, 2020 (85 FR 4997). FDA considered a 
comment received and revised the guidance to add a reference to an 
applicable FDA guidance, ``Applying Human Factors and Usability 
Engineering to Medical Devices.''
    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 ``Arthroscopy Pump Tubing Sets Intended for 
Multiple Patient Use--Premarket Notification (510(k)) Submissions.'' 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.

II. 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Arthroscopy Pump Tubing Sets Intended 
for Multiple Patient Use--Premarket Notification (510(k)) Submissions'' 
may send an email request to [email protected] to receive an 
electronic copy of the document. Please use the document number 1500066 
and complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations have been approved by 
OMB as listed in the following table:

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                                                           OMB  Control
          21 CFR part                     Topic                No.
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807, subpart E.................  Premarket notification       0910-0120
800, 801, and 809..............  Medical Device               0910-0485
                                  Labeling Regulations.
820............................  Current Good                 0910-0073
                                  Manufacturing
                                  Practice (CGMP);
                                  Quality System (QS)
                                  Regulation.
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    Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27823 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P