Notice2021-13360
Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
June 24, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Remanufacturing of Medical Devices." This draft guidance is intended to help clarify whether activities performed on devices are likely "remanufacturing." This draft guidance also includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. This draft guidance is not final nor is it in effect at this time.
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<title>Federal Register, Volume 86 Issue 119 (Thursday, June 24, 2021)</title>
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[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33305-33307]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13360]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3741]
Remanufacturing of Medical Devices; Draft Guidance for Industry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the availability of the draft guidance entitled ``Remanufacturing of
Medical Devices.'' This draft guidance is intended to help clarify
whether activities performed on devices are likely ``remanufacturing.''
This draft guidance also includes recommendations for information that
should be included in labeling to help assure the continued quality,
safety, and effectiveness of devices that are intended to be serviced
over their useful life. This draft guidance is not final nor is it in
effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by August 23, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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 identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2018-N-3741 for ``Remanufacturing of Medical Devices.'' 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 https://
[[Page 33306]]
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 draft guidance document entitled
``Remanufacturing of Medical Devices'' to the Office of Policy,
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 or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT: Katelyn Bittleman, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4250, Silver Spring, MD 20993-0002, 240-
402-1478; Joshua Silverstein, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1615, Silver Spring, MD 20993-0002, 301-796-5155; or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
Many devices are reusable and need preventive maintenance and
repair during their useful life. For these devices, proper servicing is
critical to their continued safe and effective use. However, there is a
lack of clarity regarding the distinction between ``servicing'' and
``remanufacturing.'' FDA has been working to gain additional
perspectives on the distinction between ``servicing'' and
``remanufacturing'' and has undertaken several efforts to help promote
clarity. FDA opened a docket for public comment (81 FR 11477) and held
a public workshop (81 FR 46694) in 2016. Public comments submitted to
this docket are searchable under FDA-2016-N-0436 (<a href="https://www.regulations.gov/docket?D=FDA-2016-N-0436">https://www.regulations.gov/docket?D=FDA-2016-N-0436</a>).In 2018, FDA issued a
white paper, opened a public docket, and held a public workshop to
facilitate public discussion on the distinction between servicing and
remanufacturing. Public comments submitted to this docket are
searchable under FDA-2018-N-3741 (<a href="https://www.regulations.gov/docket?D=FDA-2018-N-3741">https://www.regulations.gov/docket?D=FDA-2018-N-3741</a>). The white paper described FDA's initial
thoughts about guiding principles, provided a flowchart with
accompanying text for understanding the distinctions, and contained a
complementary approach for software, as well as considerations for
labeling, and examples utilizing the flowchart. FDA also included
targeted questions throughout the white paper for which the Agency
sought feedback. FDA concurrently opened a docket under FDA-2018-N-3741
and held a public workshop to discuss the white paper and obtain public
comment before issuing draft guidance. FDA considered the comments from
the public docket and discussions during the public workshop in
developing this draft guidance.
Because of the apparent confusion between servicing and
remanufacturing among entities performing these activities, FDA
committed in the ``FDA Report on the Quality, Safety, and Effectiveness
of Servicing of Medical Devices'' (<a href="https://www.fda.gov/media/113431/download">https://www.fda.gov/media/113431/download</a>) to issue guidance that clarifies the difference between
servicing and remanufacturing activities. To assist with this
clarification, FDA focuses this draft guidance on those activities that
are likely remanufacturing. The determination of whether the activities
an entity performs are remanufacturing affects the applicability and
enforcement of regulatory requirements under the Federal Food, Drug,
and Cosmetic Act (FD&C Act) and its implementing regulations. FDA has
consistently enforced requirements under the FD&C Act and its
implementing regulations on entities engaged in remanufacturing,
including but not limited to registration and listing, adverse event
reporting, the Quality System regulation, and marketing submissions.
For activities involving components/parts/materials, FDA recommends
the use of the flowchart in the draft guidance to help entities
determine if their activities are likely remanufacturing. Although the
servicing and remanufacturing definitions and guiding principles in
this draft document apply to software, the flowchart should not be
applied to changes involving software. FDA has instead identified
several activities performed on software that are likely not
remanufacturing. This draft guidance also includes recommendations for
information that should be included in labeling to help assure the
continued quality, safety, and effectiveness of devices that are
intended to be serviced over their useful life. This draft guidance is
not intended to adopt significant policy changes, but to clarify FDA's
current thinking on applicable definitions, and clarify, not change,
the regulatory requirements applicable to remanufacturers.
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 current thinking of FDA on
``Remanufacturing of Medical Devices.'' 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 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 <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> or from the Center for
Biologics Evaluation and Research at <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</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 ``Remanufacturing of Medical Devices'' may send
an email request to <a href="/cdn-cgi/l/email-protection#1d5e594f55305a6874797c737e785d7b797c3375756e337a726b"><span class="__cf_email__" data-cfemail="db989f8993f69caeb2bfbab5b8be9bbdbfbaf5b3b3a8f5bcb4ad">[email protected]</span></a> to receive an electronic
copy of the document. Please use the document number 17048 and complete
title to identify the guidance you are requesting.
III. Other Issues for Consideration
FDA's white paper introduced a flowchart that the Agency was
considering proposing in draft guidance. FDA requested public comment
on this flowchart during our December 2018
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workshop and through the Docket No. FDA-2018-N-3741. While FDA has
considered all comments and made changes as appropriate, FDA received
opposing comments that suggested either no flowchart or more detail
than FDA provided in the white paper. FDA encourages all interested
stakeholders to comment on their preferred approach to help determine
whether activities are remanufacturing and their rationale for such,
using the following options: (1) No flowchart; (2) a flowchart similar
to that proposed by FDA in this draft guidance; and (3) a more detailed
flowchart, such as that proposed in comment FDA-2018-N-3741-0036.
IV. Paperwork Reduction Act of 1995
While this guidance contains no 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 and forms have been
approved by OMB as listed in the following table:
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OMB control
21 CFR part; or FDA form Topic No.
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800, 801, and 809.............. Medical Device Labeling 0910-0485
Regulations.
803............................ Medical Devices; 0910-0437
Medical Device
Reporting;
Manufacturer
Reporting, Importer
Reporting, User
Facility Reporting,
Distributor Reporting.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
807, subparts A through D...... Electronic Submission 0910-0625
of Medical Device
Registration and
Listing.
807, subpart E................. Premarket Notification. 0910-0120
Form FDA 3670.................. Adverse Event Reports/ 0910-0471
MedSun program.
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Dated: June 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13360 Filed 6-23-21; 8:45 am]
BILLING CODE 4164-01-P
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