[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33305-33307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Remanufacturing of Medical Devices; Draft Guidance for Industry 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the availability of the draft guidance entitled ``Remanufacturing of 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 This draft guidance is intended to help clarify 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This draft guidance also includes recommendations for information that 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 This draft guidance is not final nor is it in 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DATES: Submit either electronic or written comments on the draft 
guidance by August 23, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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: 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.
    <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 https://www.regulations.gov 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 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://

[[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 (https://www.regulations.gov/docket?D=FDA-2016-N-0436).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 (https://www.regulations.gov/docket?D=FDA-2018-N-3741). 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'' (https://www.fda.gov/media/113431/download) 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 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products or from the Center for 
Biologics Evaluation and Research at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. 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 ``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

[[Page 33307]]

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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