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[Federal Register Volume 89, Number 228 (Tuesday, November 26, 2024)]
[Notices]
[Pages 93297-93299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27661]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-2274]

Transitional Enforcement Policy for Ethylene Oxide Sterilization 
Facility Changes for Class III Devices; 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 ``Transitional 
Enforcement Policy for Ethylene Oxide Sterilization Facility Changes 
for Class III Devices.'' This guidance provides information regarding 
FDA recommendations and general principles to be referenced by holders 
of premarket approval applications (PMAs) and humanitarian device 
exemptions (HDE) for class III devices sterilized by

[[Page 93298]]

ethylene oxide (EtO) whose products are affected by the potential, 
actual, or temporary stop or reduction of operations at a sterilization 
facility, if they wish to have FDA consider whether the exercise of 
enforcement discretion relating to the implementation of certain types 
of sterilization site changes is appropriate. FDA is issuing this 
guidance to provide an enforcement discretion policy to help 
proactively address manufacturing limitations or supply chain issues 
due to disruptions caused by closures or potential closures of 
sterilization facilities that use EtO as a medical device sterilant 
during the time in which manufacturers are transitioning to compliance 
with certain new requirements. FDA believes that the enforcement 
discretion policy described in this guidance may help address concerns 
during this time related to potential sterile medical device impacts 
affecting certain devices sterilized by EtO, help mitigate possible 
interruptions in sterile device processing, and help maintain adequate 
supplies of finished sterile medical devices. This guidance has been 
implemented without prior comment, but it remains subject to comment in 
accordance with the Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal 
Register on November 26, 2024.

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:
     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-2024-D-2274 for ``Transitional Enforcement Policy for Ethylene 
Oxide Sterilization Facility Changes for Class III 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 
``Transitional Enforcement Policy for Ethylene Oxide Sterilization 
Facility Changes for Class III Devices'' to the Office of Policy, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993-0002, 301-
796-6476; 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

    FDA is announcing the availability of a final guidance for industry 
and FDA staff entitled ``Transitional Enforcement Policy for Ethylene 
Oxide Sterilization Facility Changes for Class III Devices.'' FDA plays 
a critical role in helping to protect the medical device supply chain 
and to prevent and mitigate potential medical product impacts. As part 
of this work, FDA closely monitors the supply chain effects of closures 
and potential closures of sterilization facilities that use EtO gas to 
sterilize medical devices prior to their use. For many medical devices, 
sterilization with EtO may be the only method that effectively 
sterilizes and does not damage the device during the sterilization 
process. To help maintain patient access to

[[Page 93299]]

sterile medical devices and mitigate risks to the sterile device supply 
chain, FDA has been developing solutions to avoid potential device 
impacts during the time in which manufacturers are transitioning to 
compliance with certain new requirements for the use of EtO as a 
sterilant.
    FDA believes that the temporary enforcement discretion policy set 
forth in this guidance may help address urgent public health concerns 
related to potential sterile medical device impacts affecting certain 
devices sterilized by EtO. Specifically, this guidance is intended to 
provide information regarding what guiding principles FDA will consider 
and what types of information submitted by industry would be helpful to 
FDA to determine, on a case-by-case basis, whether to not object to 
sterilization site changes geared specifically to PMA and HDE holders 
of approved class III devices sterilized by EtO prior to the approval 
of a PMA or HDE supplement. This approach is intended to help firms 
more quickly and proactively manage the possible timeframes associated 
with implementing changes in the manufacturing site and any processes, 
methods, procedures, qualifications, and validations to help minimize 
impacts to the supply chain for EtO-sterilized class III devices. 
Further, this document is intended to be considered alongside other 
applicable FDA guidance documents, such as ``Manufacturing Site Change 
Supplements: Content and Submission,'' (hereafter ``Site Change 
Supplement Guidance'') issued December 17, 2018.
    This guidance is being implemented without prior public comment 
because FDA has determined that prior public participation for this 
guidance is not feasible or appropriate (see section 701(h)(1)(c) of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
371(h)(1)(C)) and 21 CFR 10.115(g)(2)). The immediate implementation of 
this guidance document is necessary to help protect the sterile device 
supply chain and is in the interest of proposing a less burdensome 
policy consistent with public health. FDA believes that the enforcement 
discretion policy described in this guidance may mitigate possible 
interruptions in sterile device processing and help maintain adequate 
supplies of finished sterile medical devices. Expedited sterilization 
site changes may be needed due to ongoing changes in the medical device 
sterilization landscape to reduce the likelihood of impact for certain 
EtO sterilized devices due to a potential, actual, or temporary stop or 
reduction of operations at a sterilization facility that sterilizes 
those devices. Although this policy is being implemented immediately 
without prior comment, it remains subject to comment in accordance with 
FDA's good guidance practices regulation (21 CFR 10.115(g)(3)(D)). FDA 
will consider all comments received and revise the guidance document as 
appropriate.
    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 ``Transitional Enforcement Policy for 
Ethylene Oxide Sterilization Facility Changes for Class III 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 
``Transitional Enforcement Policy for Ethylene Oxide Sterilization 
Facility Changes for Class III Devices'' may send an email request to 
[email protected] to receive an electronic copy of the 
document. Please use the document number GUI00007027 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 (44 U.S.C. 3501-3521). The collections of information in 
the following table have been approved by OMB:

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  21 CFR Part; Guidance; or FDA
              Form                       Topic          OMB control No.
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814, subparts A through E.......  Premarket approval.          0910-0231
814, subpart H..................  Humanitarian Use             0910-0332
                                   Devices;
                                   Humanitarian
                                   Device Exemption.
``Requests for Feedback and       Q-submissions and            0910-0756
 Meetings for Medical Device       Early Payor
 Submissions: The Q-Submission     Feedback Request
 Program''.                        Programs for
                                   Medical Devices.
820.............................  Current Good                 0910-0073
                                   Manufacturing
                                   Practice (CGMP);
                                   Quality System
                                   (QS) Regulation.
807, subparts A through D.......  Electronic                   0910-0625
                                   Submission of
                                   Medical Device
                                   Registration and
                                   Listing.
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    Dated: November 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-27661 Filed 11-25-24; 8:45 am]
BILLING CODE 4164-01-P
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