Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Notices 30957 

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. 

The grant application also expands 

requirements for partnerships with 

domestic violence service providers to 

address the access issues experienced 

by marginalized victims of domestic 

violence. 

Respondents: Recipients of the State 

Access and Visitation Grant (54 states 

and territories). 

ANNUAL BURDEN ESTIMATES

Instrument Total number 

of respondents 

Total number of 

responses 

per respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Annual 

burden hours 

State Access and Visitation Grant Application .................. 54 1 10 540 180 

Estimated Total Annual Burden 

Hours: 180. 

Authority: Sec. 469B(e)(3), Pub. L. 

104–193. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2022–10832 Filed 5–19–22; 8:45 am] 

BILLING CODE 4184–41–P 

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. 

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, 

clarence.murray@fda.hhs.gov. 

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. 

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 


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2Further, 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/fdavoices/fdas-budget-medical-device-supply-chainand-shortages-prevention-program. 

3FDA 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. 

§ 807.81(a)(3)(ii). Such changes fall outside the 

scope of this pilot program. 

4FDA 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/searchfda-guidance-documents/deciding-when-submit510k-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. 

5Whenever 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 §§ 820.30(i) and 820.70(b). 

6See 21 CFR 3.2(e). 

7Under § 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 

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

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 § 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. 

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. 

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 EtOsterilized 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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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 § 807.81. This guidance is 

available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/ 

deciding-when-submit-510k-change-existing-device. 

8The 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. 

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-approvalpma/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 devicespecific 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/generalhospital-devices-and-supplies/ethyleneoxide-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/statementconcerns-medical-device-availabilitydue-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/generalhospital-devices-and-supplies/fdainnovation-challenge-1-identify-newsterilization-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/generalhospital-devices-and-supplies/fdainnovation-challenge-2-reduce-ethyleneoxide-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/advisorycommittee-calendar/november-6-7-2019- 

general-hospital-and-personal-usedevices-panel-medical-devices-advisorycommittee. 

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-fdaguidance-documents/deciding-whensubmit-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-sterilityinformation-premarket-notification510k-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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidances; Draft and 

Revised Draft Guidances for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of 

additional draft and revised draft 

product-specific guidances. The 

guidances provide product-specific 

recommendations on, among other 

things, the design of bioequivalence 

(BE) studies to support abbreviated new 

drug applications (ANDAs). In the 

Federal Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website. The guidances 

identified in this notice were developed 

using the process described in that 

guidance. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by July 19, 2022 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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– 

2007–D–0369 for ‘‘Product-Specific 

Guidances; Draft and Revised Draft 

Guidances for Industry.’’ 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)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Christine Le, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4714, Silver Spring, 

MD 20993–0002, 301–796–2398, PSGQuestions@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs. 

As described in that guidance, FDA 

adopted this process as a means to 


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