Notice2021-27823
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
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Published
December 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 244 (Thursday, December 23, 2021)</title>
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[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72976-72978]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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 <a href="/cdn-cgi/l/email-protection#da999e8892f79dafb3bebbb4b9bf9abcbebbf4b2b2a9f4bdb5ac"><span class="__cf_email__" data-cfemail="8fcccbddc7a2c8fae6ebeee1eceacfe9ebeea1e7e7fca1e8e0f9">[email protected]</span></a> 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:
[[Page 72978]]
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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
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