Notice2022-10925
Medical Devices; 510(k) Sterility Change Master File Pilot Program
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Published
May 20, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its 510(k) Sterility Change Master File Pilot Program ("510(k) Sterility Pilot Program"). The 510(k) Sterility Pilot Program is voluntary and intends to give interested companies that terminally sterilize single- use devices ("sterilization providers") using certain sterilization methods a pathway to submit a Master File for FDA's review. FDA will accept a Master File into the 510(k) Sterility Pilot Program when it determines, among other things, that there is not a likelihood that switching from a fixed chamber ethylene oxide (EtO) sterilization method to the sterilization method described in the Master File could significantly affect the safety or effectiveness of a 510(k)-cleared device that meets the product definition in the Master File and that satisfies other conditions outlined in this document. If a Master File is accepted into the 510(k) Sterility Pilot Program, manufacturers of 510(k)-cleared devices ("510(k) holders") may choose to reference the Master File in internal documentation in support of a justification for not submitting a new premarket notification (510(k)) under certain conditions as outlined in this document. This voluntary pilot program seeks to encourage industry to consider new, innovative ways to sterilize devices that reduce the potential impact of EtO on the environment and on public health, while ensuring consistent patient access to safe devices and providing a framework for future regulatory approaches that would help address potential device shortages related to EtO sterilization.
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<title>Federal Register, Volume 87 Issue 98 (Friday, May 20, 2022)</title>
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[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Pages 30957-30961]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-10925]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0517]
Medical Devices; 510(k) Sterility Change Master File Pilot
Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration's (FDA, Agency, or we) Center
for Devices and Radiological Health (CDRH or Center) is announcing its
510(k) Sterility Change Master File Pilot Program (``510(k) Sterility
Pilot Program''). The 510(k) Sterility Pilot Program is voluntary and
intends to give interested companies that terminally sterilize single-
use devices (``sterilization providers'') using certain sterilization
methods a pathway to submit a Master File for FDA's review. FDA will
accept a Master File into the 510(k) Sterility Pilot Program when it
determines, among other things, that there is not a likelihood that
switching from a fixed chamber ethylene oxide (EtO) sterilization
method to the sterilization method described in the Master File could
significantly affect the safety or effectiveness of a 510(k)-cleared
device that meets the product definition in the Master File and that
satisfies other conditions outlined in this document. If a Master File
is accepted into the 510(k) Sterility Pilot Program, manufacturers of
510(k)-cleared devices (``510(k) holders'') may choose to reference the
Master File in internal documentation in support of a justification for
not submitting a new premarket notification (510(k)) under certain
conditions as outlined in this document. This voluntary pilot program
seeks to encourage industry to consider new, innovative ways to
sterilize devices that reduce the potential impact of EtO on the
environment and on public health, while ensuring consistent patient
access to safe devices and providing a framework for future regulatory
approaches that would help address potential device shortages related
to EtO sterilization.
DATES: FDA is seeking participation in the voluntary 510(k) Sterility
Pilot Program beginning May 20, 2022. See the ``Participation'' section
for selection criteria for sterilization providers to participate in
the 510(k) Sterility Pilot Program and the ``Procedures'' section for
instructions on how to submit a Master File for consideration for
inclusion into the 510(k) Sterility Pilot Program. Up to nine eligible
sterilization providers may be selected for participation in the 510(k)
Sterility Pilot Program.
FOR FURTHER INFORMATION CONTACT: Clarence W. Murray, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4536, Silver Spring MD 20993, 301-796-
0270, <a href="/cdn-cgi/l/email-protection#03606f6271666d60662d6e767171627a436567622d6b6b702d646c75"><span class="__cf_email__" data-cfemail="fb98979a899e95989ed5968e89899a82bb9d9f9ad5939388d59c948d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
EtO sterilization is an important sterilization method that is
widely used to keep devices safe. It is estimated that approximately 50
percent of all sterile devices in the United States are sterilized
using EtO (Ref. 1). For many devices, sterilization with EtO may be the
only method \1\ currently evaluated that effectively sterilizes and
does not damage the device during the sterilization process. However,
there have been concerns about the effects of EtO exposure and
environmental emissions.
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\1\ In this notice, ``method'' generally refers to the type of
sterilization and ``processes'' generally refers to steps within
that method to achieve a sterile device.
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In 2019, FDA was made aware of closures of device sterilization
facilities due to concerns about the level of EtO emissions (Ref. 2).
The Agency closely monitored the situation and worked with device
manufacturers affected by the closures to minimize impact to patients
who needed device access. Future losses of sterilization capacity due
to facility closure have the potential to result in shortages of
sterile devices if an alternative for sterilization is not readily
available for the devices sterilized at a closed facility. FDA
continues to work with manufacturers on site changes, engage with
manufacturers about potential solutions to shortage concerns, and
collaborate with external stakeholders to help reduce barriers to the
utilization of innovative device sterilization technologies. FDA has
also taken several actions to advance device sterilization, including
sponsoring two innovation challenges to identify alternatives to EtO
sterilization methods (Ref. 3) and approaches to reduce EtO emissions
(Ref. 4); convening the General Hospital and Personal Use Devices Panel
on November 6 and 7, 2019 (``November 2019 Panel Meeting''), to discuss
the role of EtO sterilization in maintaining public health (84 FR
46546, September 9, 2019; see also Ref. 5); and announcing an Ethylene
Oxide Sterilization Master File Pilot Program (``EtO Pilot Program'')
for devices subject to Premarket Application (``PMA'') approval (84 FR
65162, November 26, 2019; see also Ref. 1).
For devices subject to 510(k) requirements, before most sterile
devices are cleared for marketing, FDA reviews the submitted 510(k)
information to determine, among other considerations, if the provided
sterility information is adequate (e.g., in accordance with
internationally agreed upon voluntary consensus standards that FDA
recognizes). In some cases, if a device manufacturer changes the
sterilization method or process for sterilizing the device identified
in its original 510(k) submission, the manufacturer may need to submit
a new 510(k) for FDA review of these changes and clearance prior to
marketing (Ref. 6). However, in addition to public
[[Page 30958]]
health and environmental concerns regarding EtO emissions, FDA
recognizes the need to facilitate timely sterilization method changes
to keep device supply chain interruptions at a minimum and to
facilitate changes to sterilization processes that utilize reduced EtO
concentrations or that utilize other sterilization methods. At the
November 2019 Panel Meeting, FDA received feedback from Panel members
and stakeholders that the Agency could help prevent device shortages
and advance device sterilization by facilitating the development and
utilization of safe and effective alternative sterilization methods
that 510(k) holders may wish to consider for select sterile devices
(Ref. 5).\2\
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\2\ Further, FDA more generally seeks to improve and strengthen
the device supply chain through other broader initiatives, such as
the planned Resilient Supply Chain and Shortages Prevention Program
(RSCSPP). See FDA's Budget, Medical Device Supply Chain and
Shortages Prevention Program, <a href="https://www.fda.gov/news-events/fda-voices/fdas-budget-medical-device-supply-chain-and-shortages-prevention-program">https://www.fda.gov/news-events/fda-voices/fdas-budget-medical-device-supply-chain-and-shortages-prevention-program</a>.
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In general, a change from a fixed chamber EtO sterililzation method
to a sterilization method characterized as ``Established Category B''
or ``Novel'' by FDA's guidance, Submission and Review of Sterility
Information in Premarket Notification (510(k)) Submissions for Devices
Labeled as Sterile (Ref. 7), would likely require a new 510(k) because
this change could significantly affect the safety or effectiveness of
the device (Ref. 6).\3\ Under Sec. 807.81(a)(3)) 21 CFR 807.81(a)(3),
the submission of a new 510(k) is required prior to a change or
modification that could significantly affect the safety or
effectiveness of the device, or that is a major change or modification
in the intended use of the device. However, FDA also recognizes that
for some 510(k)-cleared devices, a change from a fixed chamber EtO
sterilization method to an Established Category B or Novel method does
not typically significantly affect the safety or effectiveness of the
device in certain cases, and therefore may not require submission of a
new 510(k) in these cases.
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\3\ FDA also notes that changes that constitute a major change
or modificiation in the intended use of a device would require a new
510(k) submission. Sec. 807.81(a)(3)(ii). Such changes fall outside
the scope of this pilot program.
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For these reasons, FDA is announcing and soliciting participation
in the 510(k) Sterility Pilot Program. Under this pilot program,
sterilization providers that sterilize single-use devices using certain
sterilization methods characterized as ``Established Category B'' or
``Novel'' may submit a Master File for their sterilization method for
FDA review.\4\ This review would include consideration of various
evaluation and validation methods (described below) that a
sterilization provider would ultimately propose to a 510(k) holder
interested in implementing a sterilization method other than fixed
chamber EtO sterilization. Interested 510(k) holders may use this
information in reaching device-specific determinations of whether a
change in sterilization method from fixed chamber EtO sterilization to
the alternative sterilization method could significantly affect safety
or effectiveness of the subject device. For 510(k) holders who are
granted a right of reference to an accepted Master File for a
particular 510(k)-cleared device under the conditions described below,
FDA believes there is a likelihood that switching to the sterilization
method described in the Master File could not significantly affect the
safety or effectiveness of such device. Accordingly, if a Master File
submitted by a 510(k) holder's sterilization provider is accepted by
FDA, the 510(k) holder could, under certain conditions and on a
voluntary basis, reference the Master File in the 510(k) holder's
internal documentation,\5\ without submitting a new 510(k) for a
sterilization method change from a fixed chamber EtO method to the
method described in the Master File. The pilot program is intended to
provide expeditious review and feedback to sterilization providers on
Master File submissions that may support sterilization changes to
510(k) cleared devices. FDA intends to evaluate pilot participation and
the progress of the pilot in 6 months and provide any updates to the
pilot in a subsequent notice, if appropriate. At this time, 510(k)s
reviewed by the Center for Biologics Evaluation and Research (CBER) and
510(k)s for combination products \6\ are outside the scope of this
pilot.
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\4\ FDA is not including ``Established Category A'' methods
within the scope of the pilot program at this time. Manufacturers of
510(k) devices seeking to change from a fixed chamber EtO
sterilization method to an ``Established Category A'' method should
evaluate the change according to FDA's guidance, ``Deciding When to
Submit a 510(k) for a Change to an Existing Device'' in determining
whether a new 510(k) is required (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device</a>). In general, for changes from
one ``Established Category A'' method to another ``Established
Category A'' method, it is unlikely submission of a new 510(k) is
required if the change could not significantly affect the
performance or biocompatibility of the device, or constitute a major
change or modification in the intended use of the device.
\5\ Whenever a manufacturer changes its device, it must take
certain actions to comply with the Quality System Regulation (QSR),
part 820 (21 CFR part 820), unless a regulatory exemption exists.
The QSR requires that design changes and production and process
changes be documented prior to implementation. See Sec. Sec.
820.30(i) and 820.70(b).
\6\ See 21 CFR 3.2(e).
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For the purposes of this document, the term ``sterilization
provider'' is used to refer to a device manufacturer's own in-house
sterilization facility or a device manufacturer's contract
sterilization provider, and encompasses any subcontractor facilities
utilizing the same quality system as the contract sterilization
provider, as applicable. This document and the proposed 510(k)
Sterility Pilot Program do not otherwise remove or replace applicable
statutory or regulatory requirements for EtO-sterilized devices subject
to 510(k) submissions.
A. Participation
Up to nine sterilization providers may be eligible to participate
in this voluntary 510(k) Sterility Pilot Program. The pilot program is
limited to sterilization providers that meet the following selection
qualities:
1. Be a sterilization provider of a single-use device that is
provided sterile;
2. Be in good compliance standing with the Agency; and
3. Submit a Master File in accordance with the procedures set forth
in section I.B for a validated sterilization method that may be
considered an ``Established Category B'' or ``Novel'' sterilization
method as described in FDA's guidance entitled Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions
for Devices Labeled as Sterile (Ref. 7).
The following are outside the scope of the 510(k) Sterility Pilot
Program and are inappropriate for inclusion in this program:
1. Reusable devices, reprocessed single-use devices, or devices
that are provided non-sterile.
2. Combination products.
3. Devices regulated by CBER.
4. Changes to device design, specifications, or materials.
5. Sterilization changes for which there is a likelihood that the
change could significantly affect device specifications, device
performance, material compatibility, or biocompatibility, or otherwise
could significantly affect device safety or
effectiveness.<SUP>7 8</SUP>
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\7\ Under Sec. 807.81(a)(3), the submission of a new 510(k) is
required prior to a change or modification that could significantly
affect the safety or effectivess of the device, or that is a major
change or modification in the intended use of the device. FDA's
guidance entitled ``Deciding When to Submit a 510(k) for a Change to
an Existing Device'' discusses specific factors to consider when
assessing if a change to a 510(k) cleared device, including a
sterilization change, may require a new 510(k) pursuant to Sec.
807.81. This guidance is available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device</a>.
\8\ The responsibility for determining whether a change from EtO
sterilization to the sterilization method described in a Master File
could significantly affect the safety or effectiveness of a
particular 510(k)-cleared device continues to rest with the 510(k)
holder. FDA's acceptance of a Master File into the 510(k) Sterility
Pilot Program should not be understood to supplant a 510(k) holder's
obligation to conduct a device-specific evaluation of whether the
change described in the Master File could significantly affect the
safety or effectiveness of a device in a particular case.
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[[Page 30959]]
6. Sterilization processes used only for intermediate processing
prior to final device assembly.
7. Devices with alternate sterility assurance levels (SAL) other
than 10<SUP>-6</SUP>.
B. Procedures
While the sterilization provider serves as the primary participant
of the 510(k) Sterility Pilot Program, FDA anticipates that close
collaboration between sterilization providers and 510(k) holders will
be necessary to ensure the success of the pilot program. Accordingly,
the procedures for sterilization providers and 510(k) holders are set
forth below.
1. Procedures for Sterilization Providers
To be considered for the voluntary 510(k) Sterility Pilot Program,
a sterilization provider should submit the following information in a
Master File for the Agency's review with a cover sheet clearly
indicating ``510(k) Sterility Change Master File Pilot Program'' in the
subject heading:
1. Name, address, and FDA Establishment Identification (FEI) number
of the sterilization facility.
2. Clear identification of all responsibilities of the
sterilization facility and device manufacturers with respect to
sterilization validation.
3. Information regarding the sterilization method and the
operations of the sterilization provider including:
<bullet> Methodology for Installation Qualification, Operational
Qualification, and Performance Qualification.
<bullet> Installation and operational requalification schedule to
support continuous process effectiveness.
<bullet> Identification and explanation of management structure and
involvement for process and facility review.
<bullet> Identification and description of a structured program and
schedule for independent audits and monitors.
<bullet> The sterilization facility's inspectional history and
history of compliance with applicable regulations (including, but not
limited to, requirements under part 820 (21 CFR part 820).
<bullet> Identification and explanation of common potential
protocol deviations, along with proposed mitigation of potential
deviations. The Master File should also include a strategy to address
any deviations that could significantly affect the safety or
effectiveness of a device and any deviations not addressed in the
Master File.
4. Technical information regarding the sterilization method:
<bullet> A description of the sterilization system including system
specifications, process parameters and monitors, and a description of
the hardware components in the sterilization system.
<bullet> An overview of the sterilization cycle(s) and process
definition that includes an overview and discussion of the
sterilization process and cycle profile(s), as well as a detailed
description of the critical parameters, specific exposure conditions
for cycles, sterilant, sterilant concentration, and sterilant shelf-
life.
<bullet> A description of the intended sterilization load and
product definition that includes defining the critical load
characteristics and ranges, and describes the procedure used to
determine if a device meets the product definition.
<bullet> Generally applicable microbiological testing information
and the validation methodology and results used to demonstrate that the
process can achieve an SAL of 10<SUP>-6</SUP> when carried out on a
device. This information should support that the test microorganism(s)
used to validate and monitor the sterilization cycle is the most
resistant microorganism(s) and provide resistance characteristics for
the most resistant microorganism(s). This testing may include
sporicidal testing, D-value determination based upon survivor curve
analysis and fraction negative analysis, half cycle testing, total kill
endpoint testing, and external process challenge device (ePCD) and
internal process challenge device (iPCD) lethality testing. The
generalized sterilization method development and validation information
provided in the proposed Master File should be consistent with ANSI/
AAMI/ISO 14937:2009/(R)2013, Sterilization of health care products--
General requirements for characterization of a sterilizing agent and
the development, validation and routine control of a sterilization
process for medical devices.
<bullet> A summary of how the biological performance testing is
used to define process parameters, and a summary of physical tests
which demonstrate that the sterilizer achieves and maintains the
required physical/chemical process lethality conditions within
specifications. These data should be from repeated runs with varying
load conditions (e.g., minimum and maximum loading configurations).
<bullet> A description of the validated biological and/or chemical
indicators used with the sterilization method and how the indicators
are used to monitor sterilization cycles. Describe the types of
packaging used with the validated cycles in order to maintain
sterility.
<bullet> Identification of compatible/incompatible materials and
describe how material compatibility is assessed for devices sterilized
with the method.
<bullet> A description of how biocompatibility is assessed for
devices that are switched to the method to ensure that biocompatibility
is not significantly affected, and an assessment of toxicity for the
sterilant and any common byproducts. Describe how removal or
dissipation of the sterilant and byproducts is achieved.
<bullet> Identification of all relevant consensus standards used
and any aspects of the standards that were not met. Deviations should
be identified, addressed and justified or mitigated, as applicable.
<bullet> If leveraging or referencing previous interactions with
FDA (e.g., Innovation Challenge discussions, Q-Submissions, etc.) in
the Master File, provide the submission number as a reference.
For more information on Master Files, see FDA's website: <a href="https://www.fda.gov/medical-devices/premarket-approval-pma/master-files">https://www.fda.gov/medical-devices/premarket-approval-pma/master-files</a>.
Following receipt of a Master File containing the information
described in section I.B.1 of this document, FDA will determine
eligibility for the pilot program by evaluating whether the criteria
outlined in Sections I.A and I.B.1 of this document have been met, and
provide written feedback that FDA either accepts the Master File into
the 510(k) Sterility Pilot Program or has determined that the Master
File is outside the scope of the pilot program. FDA intends to work
interactively with the Master File holder to address any deficiencies
with the information provided in the Master File. If a Master File is
outside the scope of the pilot program, the written feedback will
identify the reasons the Master File was determined to be out of scope.
If accepted into the pilot program, the Master File holder should
submit amendments to FDA every 6 months with information on any process
changes, a list of devices for which the sterilization method has been
changed from fixed chamber EtO sterilization to the sterilization
method described in the
[[Page 30960]]
Master File and for which a right of reference to the Master File has
been granted (except devices which have already been identified in a
prior amendment), and any other changes to the information contained in
the Master File, to maintain participation in the pilot program. If
there have been no updates or changes, the Master File holder should
notify FDA of the absence of any updates or changes in lieu of
submitting an amendment. The description included in the amendments of
devices for which the sterilization method has been changed from fixed
chamber EtO sterilization to the sterilization method described in the
Master File, and for which a right of reference to the Master File has
been granted, should include:
1. The manufacturer(s) of the device(s);
2. Each device name;
3. The 510(k) number(s) for the device(s); and
4. A description of how each device added to the Master File meets
the product definition in the accepted Master File.
This information may be used to inform FDA's understanding of how
the product definition is being interpreted and applied in practice.
Following receipt of an amendment, FDA will evaluate whether the Master
File, as amended, remains within the scope of the pilot program, and
will notify the Master File holder that FDA either accepts the
amendment, or has determined that the amendment, in whole or in part,
would cause the Master File to be outside the scope of the pilot
program.
If a sterilization provider is accepted into the pilot program and
does not maintain participation (e.g., through non-submission of
amendments, updates, or other information requested by FDA under the
pilot program) or no longer wishes to participate in the pilot program,
the sterilization provider should notify 510(k) holders for whom they
granted a right of reference to the Master File. If the Master File
holder does not maintain participation in the pilot program, FDA may
determine that the Master File for that sterilization process is
outside the scope of the pilot program.
2. Procedures for 510(k) Holders
510(k) holders who wish to change their sterilization method for a
previously cleared device from a fixed chamber EtO sterilization method
to the sterilization method described in a Master File that has been
accepted into the pilot program should use the following procedures.
Once a sterilization provider has proposed, and FDA has accepted, a
Master File into the pilot program, interested 510(k) holders may
choose to review the information in the Master File in carrying out
device-specific analyses of whether the alternative sterilization
method could significantly affect safety or effectiveness. If the
510(k) holder has determined that the alternative sterilization method
could not significantly affect safety or effectiveness of the subject
device, and if the 510(k) holder has a right of reference to the Master
File granted by the Master File holder, the 510(k) holder may reference
the Master File in internal documentation supporting the change from a
fixed chamber EtO sterilization method to the method described in the
referenced Master File. The internal documentation supporting the
change should include:
1. Name, address, and FEI number of the sterilization facility.
2. Master File number in which the referenced sterilization
procedures are described, with signed right of reference from the
Master File holder identifying the devices to be sterilized under the
Master File.
3. List of device(s) to be sterilized (identified by manufacturer,
trade name, model number, and 510(k) number).
4. A summary of the information used to support the conclusion of
the 510(k) holder that the method described in the Master File achieves
an SAL of 10<SUP>-6</SUP> for the subject device and that the
sterilization method could not significantly affect the device's
design, specifications, performance, or biocompatibility, or otherwise
could not significantly affect device safety or effectiveness.
This Pilot Program does not otherwise remove or replace any
requirements, such as, but not limited to, recordkeeping requirements
under part 820, premarket notification requirements under part 807 (21
CFR part 807), subpart E, and labeling requirements under 21 CFR part
801. It is the manufacturer's responsibility to ensure compliance with
applicable laws and regulations.
During this voluntary 510(k) Sterility Pilot Program, CDRH staff
intends to be available to answer questions or concerns that may arise.
The 510(k) Sterility Pilot Program participants may comment on and
discuss their experiences with the Center.
II. Paperwork Reduction Act of 1995
This notice refers to previously approved collections of
information found in FDA regulations. These 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. 3501-3520). The
collections of information in part 820, regarding the Quality System
regulations, have been approved under OMB control number 0910-0073. The
collections of information in part 807, subpart E, regarding premarket
notification submission, have been approved under OMB control number
0910-0120.
III. References
The following references are on display in the Dockets Management
Staff (see ADDRESSES), and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. U.S. Food and Drug Administration, ``Ethylene Oxide Sterilization
for Medical Devices,'' available at: <a href="https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices">https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices</a>.
2. U.S. Food and Drug Administration, ``Statement on Concerns With
Medical Device Availability Due to Certain Sterilization Facility
Closures,'' available at: <a href="https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures">https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures</a>.
3. U.S. Food and Drug Administration, ``FDA Innovation Challenge 1:
Identify New Sterilization Methods and Technologies,'' available at:
<a href="https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-1-identify-new-sterilization-methods-and-technologies">https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-1-identify-new-sterilization-methods-and-technologies</a>.
4. U.S. Food and Drug Administration, ``FDA Innovation Challenge 2:
Reduce Ethylene Oxide Emissions,'' available at: <a href="https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-2-reduce-ethylene-oxide-emissions">https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-2-reduce-ethylene-oxide-emissions</a>.
5. U.S. Food and Drug Administration, ``November 6 and 7, 2019:
General Hospital and Personal Use Devices Panel of the Medical
Devices Advisory Committee Meeting Announcement,'' available at:
<a href="https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-7-2019-general-hospital-and-personal-use-devices-panel-medical-devices-advisory-committee">https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-7-2019-general-hospital-and-personal-use-devices-panel-medical-devices-advisory-committee</a>.
6. U.S. Food and Drug Administration, ``Deciding When to Submit a
510(k) for a Change to an Existing Device,'' available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device</a>.
[[Page 30961]]
7. U.S. Food and Drug Administration, ``Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions
for Devices Labeled as Sterile,'' available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled</a>.
Dated: May 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10925 Filed 5-19-22; 8:45 am]
BILLING CODE 4164-01-P
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