[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
------------------------------------------------------------------------
OMB control
21 CFR part or FDA form Topic No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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