[Federal Register Volume 89, Number 92 (Friday, May 10, 2024)]
[Notices]
[Pages 40490-40492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10230]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3741]


Remanufacturing of Medical Devices; Guidance for Industry, 
Entities That Perform Servicing or Remanufacturing, 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 ``Remanufacturing of 
Medical Devices.'' This final guidance is intended to help clarify 
whether activities performed on devices are likely ``remanufacturing.'' 
This final guidance also clarifies existing regulatory requirements for 
remanufacturers and 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.

DATES: The announcement of the guidance is published in the Federal 
Register on May 10, 2024.

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

[[Page 40491]]

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 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.
     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 
``Remanufacturing of Medical Devices'' 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: 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; or James Myers, 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'' activities. FDA has been working to promote clarity 
on the distinction between ``servicing'' and ``remanufacturing.''
    FDA opened a docket for public comment (81 FR 11477) and held a 
public workshop (81 FR 46694) in 2016. The Food and Drug Administration 
Reauthorization Act (FDARA) became law on August 18, 2017. Section 710 
of FDARA charged the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, to issue a report on the 
continued quality, safety, and effectiveness of medical devices with 
respect to servicing. In May 2018, FDA published on its website the 
report entitled ``FDA Report on the Quality, Safety, and Effectiveness 
of Servicing of Medical Devices'' (https://www.fda.gov/media/113431/download). One conclusion of the report stated ``a majority of 
comments, complaints, and adverse event reports alleging that 
inadequate `servicing' caused or contributed to clinical adverse events 
and deaths actually pertain to `remanufacturing' and not `servicing,' 
'' and FDA committed to issue guidance that clarifies the difference 
between servicing and remanufacturing activities. In December 2018, FDA 
issued a white paper entitled ``Evaluating Whether Activities are 
Servicing or Remanufacturing'' (https://www.fda.gov/media/117238/download), opened a public docket (FDA-2018-N-3741), and held a public 
workshop (https://wayback.archive-it.org/7993/20201222125933/https:/www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-workshop-medical-device-servicing-and-remanufacturing-activities-december-10-11-2018-12102018) to facilitate public 
discussion on the distinction between servicing and remanufacturing. 
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 on which the Agency sought feedback. FDA

[[Page 40492]]

considered the comments from the public docket and discussions during 
the public workshop in developing the draft guidance. A notice of 
availability of the draft guidance appeared in the Federal Register of 
June 24, 2021 (86 FR 33305).
    FDA focuses this guidance on activities that are likely 
remanufacturing--processing, conditioning, renovating, repackaging, 
restoring, or any other act done to a finished device that 
significantly changes the finished device's performance or safety 
specifications, or intended use (see 21 CFR 820.3(w)). 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.
    FDA considered comments received and revised the guidance as 
appropriate. In this final guidance, FDA provided additional contextual 
examples of activities throughout Section VI.B to provide further 
clarity when determining whether activities remanufacture a device. FDA 
clarified the applicability of the guidance to original equipment 
manufacturers (OEMs) and external entities on behalf of OEMs. FDA also 
added Section VIII ``Regulatory Requirements and Considerations for 
Remanufacturers'' to the guidance clarifying and outlining certain 
existing regulatory requirements that apply to remanufacturers.
    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 ``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 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``Remanufacturing of Medical Devices'' may send an email request to 
[email protected] to receive an electronic copy of the 
document. Please use the document number GUI00017048 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. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in the following table have been approved by OMB:

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                                                            OMB control
    21 CFR part or FDA form               Topic                 No.
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800, 801, 809, and 830.........  Medical Device Labeling       0910-0485
                                  Regulations; Unique
                                  Device Identification.
803............................  Medical Device                0910-0437
                                  Reporting.
Form FDA 3670..................  Adverse event reports/        0910-0471
                                  MedSun program.
806............................  Medical Devices;              0910-0359
                                  Reports of Corrections
                                  and Removals.
810............................  Medical Device Recall         0910-0432
                                  Authority.
820............................  Current Good                  0910-0073
                                  Manufacturing
                                  Practice; Quality
                                  System Regulation.
807, subparts A through D......  Electronic Submission         0910-0625
                                  of Medical Device
                                  Registration and
                                  Listing.
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
860, subpart D.................  De Novo classification        0910-0844
                                  process.
812............................  Investigational Device        0910-0078
                                  Exemption.
814, subpart H.................  Humanitarian Use              0910-0332
                                  Devices; Humanitarian
                                  Device Exemption.
1000 through 1040..............  Electronic Products           0910-0025
                                  Requirements.
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    Dated: May 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-10230 Filed 5-9-24; 8:45 am]
BILLING CODE 4164-01-P