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Today’s Topic: 

Medical Device Sterilization Town Hall: 

FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide 

January 26, 2024
Medical Device Sterilization Town Hall: 

FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide

Ryan Ortega, PhD 

Regulatory Advisor

Regulatory Policy & Combination Products Staff 

Office of Product Evaluation and Quality

LCDR Scott Steffen, PhD 

Senior Program Management Officer / EtO Incident Lead

Division of All Hazards Preparedness & Response 

Office of Readiness & Response 

Office of Strategic Partnerships and Technology Innovation 

Lisa Simone, PhD

Senior Health Scientist / EtO Incident Lead

Division of All Hazards Preparedness & Response 

Office of Readiness & Response 

Office of Strategic Partnerships and Technology Innovation 

Center for Devices and Radiological Health 

U.S. Food and Drug Administration

Aftin Ross, PhD

Deputy Director 

Office of Readiness & Response 

Office of Strategic Partnerships and Technology Innovation
3

Aftin Ross, PhD

Deputy Director 

Office of Readiness & Response 

Office of Strategic Partnerships and Technology Innovation
What we heard from you last time

4
Learning Objectives

• Describe 2019 Advisory Committee recommendations 

and FDA’s early actions to mitigate the impact of the 

potential loss of EtO sterilization capacity in the US 

• Describe FDA’s understanding of opportunities and 

challenges to using alternative sterilization modalities 

• Describe recent activities to reduce overall EtO 

reliance while maintaining a resilient supply of 

sterilized medical devices 

5
6

FEBRUARY 2019 

Sterigenics 

closure

JULY 2019 

Innovation Challenge 1: Alternatives to EtO Sterilization

Innovation Challenge 2: Reducing EtO Emissions

NOVEMBER 2019 

FDA Advisory Committee Meeting

NOVEMBER 2019 

EtO Sterilization Master File Pilot 

Program for PMA Holders

MARCH 2020 

COVID Public Health 

Emergency, CARES Act & 506J

Notifications

MAY 2022 

510(k) Sterility Change 

Master File Pilot Program

AUGUST 2022 

FDA statement supporting 

innovation in medical device 

sterilization

APRIL 2023 

Radiation Sterilization 

Master File Pilot Program for 

PMA Holders

JULY 2023 

CDRH Announces New Standards 

Recognition to Support Innovation 

in Medical Device Sterilization

MARCH 2023 

FDA forms EtO 

Tiger Team

Activity Timeline

2024

2023

2022

2021

2020

2019

NOVEMBER 2019 

FDA Statement on steps to 

advance medical device 

sterilization with EtO

JANUARY 2024 

Update to 510(k)

Sterility Guidance

JANUARY 2024 

First FDA Medical Device 

Sterilization Town Hall
7

Ryan Ortega, PhD 

Regulatory Advisor

Regulatory Policy & Combination Products Staff 

Office of Product Evaluation and Quality
Early Actions and Recommendations from 

the 2019 Advisory Committee Meeting 

8
Partnering with Industry Stakeholders: 

FDA Innovation Challenges

Challenge 1: Alternatives to EtO sterilization

– 5 applications selected

– Supercritical carbon dioxide, nitrogen dioxide, accelerator - based radiation, 

vaporized hydrogen peroxide, and vaporized hydrogen peroxide-ozone

Challenge 2: Reducing EtO emissions

– 8 applications selected

– Enhanced EtO cycle design and processes, flexible chamber, reduced sterilant 

concentration, and abatement strategy

9
2019 Advisory Committee Meeting 

Key Recommendations

• Continue to partner with industry stakeholders (e.g., EtO Innovation Challenge) 

• Consider incentive structures that may help catalyze industry EtO activities (e.g., 

Sterility Master File Pilot Programs) 

• Consider risk - based sterility assurance levels for some medical devices 

• Enhance FDA’s ability to respond to device shortages by incorporating processes 

currently used with drug shortages, if appropriate 

• Remove paper instructions from devices that are being sterilized, where possible 

• Explore alternative sterilization modalities in devices where these alternatives can 

work effectively 

• Leverage work with standards to advance alternative sterilization methods 

• Work collaboratively with other government entities, on the federal and state level 

• Facilitate collaboration with industry and communications with stakeholders

10
Incentive Structures: Sterility Master File 

Pilot Programs

• EtO Sterilization Master File Pilot Program for PMA Holders (2019) 

– allows companies that sterilize single - use medical devices using 

fixed chamber EtO to submit a Master File when making certain 

changes between sterilization processes and facilities that reduce 

the amount of EtO concentrations used to sterilize medical devices 

• 510(k) EtO Sterility Change Master File Pilot Program (2022) 

– allows companies to make changes to a cleared medical device's 

sterilization method from a fixed chamber EtO sterilization cycle to 

the sterilization method described in the Master File 

• Radiation Sterilization Master File Pilot Program (2023) 

– allows companies to make changes to or advance alternative ways 

to sterilize approved medical devices using radiation (x - ray and 

electron beam)

11 Sterilization for Medical Devices / Sterilization Master File Pilot Programs
12

Lisa Simone, PhD

Senior Health Scientist / EtO Incident Lead

Division of All Hazards Preparedness & Response 

Office of Readiness & Response 

Office of Strategic Partnerships and Technology Innovation
Ramping Up Effort for Forward Leaning 

Approaches

13
CDRH EtO Tiger Team

• Cross CDRH involvement to foster nimble 

response in advancing sterilization innovation 

• Expertise in regulatory science, regulatory 

review, policy, supply chain, incident response 

• Integrate with broader CDRH EtO - related 

activities 

• External stakeholder engagement 

• State and federal engagement 

• Medical Device Sterilization Town Hall Series 

14

Goal: Support efforts to reduce reliance on EtO for medical device 

sterilization
CDRH EtO Tiger Team

15

Review Practices 

Policy Incentives

Focal Point Programs

Sterilization SMEs

Device Shortages

Case for Quality

(OPEQ)

International Outreach

Communication Strategy

(OCD)

Regulatory Science

Sterilization SMEs

(OSEL)

Incident Response

Standards

Government Engagement

External Engagement

Project Management

(OST/ORR) Supply Chain Resiliency and 

Shortage Assessment

Data Science

External Engagement 

(OST/OSCR)

Policy/Regulatory Counsel

(OP)

Tiger Team

CDRH Offices Represented 

OST: Office of Strategic 

Partnerships and 

Technology Innovation 

ORR: Office of Readiness & 

Response

OSCR: Office of Supply Chain 

Resilience 

OPEQ: Office of Product 

Evaluation and Quality 

OSEL: Office of Science and 

Engineering 

Laboratories 

OP: Office of Policy 

OCD: Office of the Center 

Director
Stakeholder Outreach: Overview

• Engage with device manufacturers, 

sterilizers and professional organizations

– Interest/activity in using alternative gaseous or radiation - based 

sterilants for devices where EtO currently used 

– Challenges transitioning from EtO

16

Goal: Understand opportunities and 

challenges to using alternative 

sterilization modalities
Stakeholder Feedback

• Some straightforward successes shifting sterilization

modalities 

• Transitioning from EtO to another modality has 

technical, logistical and regulatory challenges 

• EtO transition plans are varied with most being longterm and requiring significant resources

17
• Aid industry understanding of regulatory 

review 

• Streamline regulatory review where 

possible 

• Coordinate with other international 

regulators 

• Collaborate with industry on

– challenging technical topics 

– educational opportunities

18

Stakeholder Outreach: How can FDA Help?
19

LCDR Scott Steffen, PhD 

Senior Program Management Officer / EtO Incident Lead

Division of All Hazards Preparedness & Response 

Office of Readiness & Response 

Office of Strategic Partnerships and Technology Innovation 
Recent Activities, Goals and Opportunities

20
Industry Activities, Data Sharing and 

Collaboration

• Reducing EtO usage, actively seeking 

alternative modalities 

• Standards - based collaborative activities 

• Voluntary reporting of medical device 

shortages 

– Submit a 506J Notification using the webform or to 

CDRHManufacturerShortage@fda.hhs.gov

• Data needs when revisiting sterilization goals 

and methods

• Further opportunities to interact

21
Recent FDA Activities

• Radiation Sterilization Master File Pilot Program 

for PMA holders (2023) 

• Leveraging standards to advance alternate 

methods: Standards List 60 recognitions (2023) 

– ISO 22441:2022 

– AAMI TIR17:2017/(R)2020

– AAMI TIR104:2022

• 510(k) Sterility Guidance update (2024) 

• Engagement in conferences and workshops

22

• Sterility focal point program harmonizing review practices across review offices
Progress on Recommendations

• Incentive structures to catalyze industry activity 

• Leveraging standards to advance alternate 

methods 

• Explore alternative modalities 

• Enhance FDA’s ability to respond to device 

shortages 

• Work collaboratively with state and federal 

entities 

• Facilitate collaboration with industry 

• Communications with stakeholders

23
Resources

Slide 

Number

Cited Resource URL

6

Sterigenics closure www.epa.gov/il/sterigenics-willowbrook-facility

6

Innovation Challenge 1: Alternatives to EtO 

Sterilization

www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovationchallenge-1-identify-new-sterilization-methods-and-technologies

6

Innovation Challenge 2: Reducing EtO Emissions www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovationchallenge-2-reduce-ethylene-oxide-emissions

6

FDA Advisory Committee Meeting www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-7-

2019-general-hospital-and-personal-use-devices-panel-medical-devices-advisorycommittee

6

EtO Sterilization Master File Pilot Program for 

PMA Holders

www.federalregister.gov/documents/2019/11/26/2019-25631/center-for-devicesand-radiological-health-ethylene-oxide-sterilization-master-file-pilot-program

6

FDA Statement on steps to advance medical 

device sterilization with EtO

www.fda.gov/news-events/press-announcements/statement-new-steps-advanceinnovation-medical-device-sterilization-ethylene-oxide

6

COVID Public Health Emergency, CARES Act & 

506J Notifications

www.fda.gov/medical-devices/medical-device-safety/medical-device-supply-chainand-shortages

6

FDA statement supporting innovation in medical 

device sterilization

www.fda.gov/news-events/press-announcements/fda-continues-efforts-supportinnovation-medical-device-sterilization

6

510(k) Sterility Change Master File Pilot 

Program

www.federalregister.gov/documents/2022/05/20/2022-10925/medical-devices510k-sterility-change-master-file-pilot-program

24
Resources

Slide 

Number

Cited Resource URL

6

Radiation Sterilization Master File Pilot Program 

for PMA Holders

www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announcesradiation-sterilization-master-file-pilot-program

6

CDRH Announces New Standards Recognition to 

Support Innovation in Medical Device 

Sterilization

www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announcesnew-standards-recognition-support-innovation-medical-device-sterilization

6 Update to 510(k) Sterility Guidance www.fda.gov/regulatory-information/search-fda-guidance-documents/submissionand-review-sterility-information-premarket-notification-510k-submissions-deviceslabeled

6

FDA Medical Device Sterilization Town Hall 

Series

www.fda.gov/medical-devices/workshops-conferences-medical-devices/medicaldevice-sterilization-town-hall-overview-sterilization-landscape-and-role-ethyleneoxide

9 Alternatives to EtO sterilization www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovationchallenge-1-identify-new-sterilization-methods-and-technologies

9

Reducing EtO emissions www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovationchallenge-2-reduce-ethylene-oxide-emissions

11 Sterilization Master File Pilot Programs www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilizationmedical-devices#MasterFile

21 Submitting a 506J using the webform fda-cdrh.my.salesforce-sites.com/shortages/

27 Sterilization for Medical Devices www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilizationmedical-devices 25
Summary

• Since FDA's 2019 Advisory Committee Meeting, FDA and 

industry have worked to reduce EtO use and encourage 

the advancement of EtO alternatives 

• The CDRH - wide EtO Tiger Team was launched to further 

support efforts to reduce reliance on EtO use for medical 

devices 

• FDA welcomes additional opportunities to engage with 

industry going forward

26
Next Town Hall

Date: Wednesday, February 7, 2024

Time: 3:00 – 4:00 pm ET

Potential Topic: 

• Premarket considerations for 

sterilization-related submissions

A new section has been added to our Sterilization for Medical Devices

27

webpage and includes town hall dates and links to town hall materials. 

Medical Device Sterilization Town Hall Series

www.fda.gov/medical-devices/general-hospitaldevices-and-supplies/sterilization-medicaldevices#town-halls

Additional Panelists

Tammy Beckham, DVM, PhD 

Office Director

Office of Supply Chain Resilience 

Office of Strategic Partnerships and Technology Innovation

Suzanne Schwartz, MD, MBA

Director 

Office of Strategic Partnerships and Technology Innovation
Let’s Take Your Questions and Comments

• To ask a question/share a comment:

• Raise your hand in Zoom

• Moderator will announce your name and invite you to speak

• Unmute yourself when prompted in Zoom to speak

• When asking a question/sharing a comment:

• Keep question/comment as short as possible

• No questions about specific submissions

• After question/comment is addressed:

• Mute yourself and lower your hand

• If you have another question/comment - raise your hand again

Additional questions/comments about today’s topic

• Email: MedicalDeviceSterilization@fda.hhs.gov
Thanks for Joining Today!

• Presentation and Transcript will be 

available at CDRH Learn

• www.fda.gov/Training/CDRHLearn

• Additional questions/comments 

about today’s presentation

• Email:

MedicalDeviceSterilization@fda.hhs.gov

• Upcoming Town Halls & Webinars 

• www.fda.gov/CDRHWebinar