Notice2024-27661
Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
November 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 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.
Full Text
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<title>Federal Register, Volume 89 Issue 228 (Tuesday, November 26, 2024)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<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-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 <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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <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>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. 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
<a href="/cdn-cgi/l/email-protection#783b3c2a30553f0d111c19161b1d381e1c195610100b561f170e"><span class="__cf_email__" data-cfemail="3c7f786e74117b4955585d525f597c5a585d1254544f125b534a">[email protected]</span></a> 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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