[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Notices]
[Pages 30957-30961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, [email protected].

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, https://www.fda.gov/news-events/fda-voices/fdas-budget-medical-device-supply-chain-and-shortages-prevention-program.
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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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device). 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.7 8
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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: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.
    \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 10-6.

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:
     Methodology for Installation Qualification, Operational 
Qualification, and Performance Qualification.
     Installation and operational requalification schedule to 
support continuous process effectiveness.
     Identification and explanation of management structure and 
involvement for process and facility review.
     Identification and description of a structured program and 
schedule for independent audits and monitors.
     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).
     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:
     A description of the sterilization system including system 
specifications, process parameters and monitors, and a description of 
the hardware components in the sterilization system.
     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.
     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.
     Generally applicable microbiological testing information 
and the validation methodology and results used to demonstrate that the 
process can achieve an SAL of 10-6 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.
     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).
     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.
     Identification of compatible/incompatible materials and 
describe how material compatibility is assessed for devices sterilized 
with the method.
     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.
     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.
     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: https://www.fda.gov/medical-devices/premarket-approval-pma/master-files.
    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

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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 10-6 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 https://www.regulations.gov. 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: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices.
2. U.S. Food and Drug Administration, ``Statement on Concerns With 
Medical Device Availability Due to Certain Sterilization Facility 
Closures,'' available at: https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures.
3. U.S. Food and Drug Administration, ``FDA Innovation Challenge 1: 
Identify New Sterilization Methods and Technologies,'' available at: 
https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-1-identify-new-sterilization-methods-and-technologies.
4. U.S. Food and Drug Administration, ``FDA Innovation Challenge 2: 
Reduce Ethylene Oxide Emissions,'' available at: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-2-reduce-ethylene-oxide-emissions.
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: 
https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-7-2019-general-hospital-and-personal-use-devices-panel-medical-devices-advisory-committee.
6. U.S. Food and Drug Administration, ``Deciding When to Submit a 
510(k) for a Change to an Existing Device,'' available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.

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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: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-information-premarket-notification-510k-submissions-devices-labeled.

    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


