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FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies

The FDA announced two public innovation challenges to encourage the development of new approaches to medical device sterilization. Challenge 1 was focused on identifying alternatives to ethylene oxide (EtO) sterilization methods.

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List of Participants Selected for Challenge 1

The FDA received 24 applications from companies large and small to this FDA innovation challenge. After careful review using an established set of criteria, the FDA selected four participants and five submissions for this challenge.

Company Reduction Technology or Strategy Category
NovaSterilis Supercritical Carbon Dioxide Sterilization
Noxilizer, Inc. Nitrogen Dioxide Sterilization
STERIS Accelerator-Based Radiation Sterilization
STERIS Vaporized Hydrogen Peroxide Sterilization
TSO3, now a part of Stryker Vaporized Hydrogen Peroxide-Ozone Sterilization

What Happens Next?

Participants selected for this challenge will work directly with the FDA to accelerate the development and review of innovative technology.

Within 60 days of announcing the participants, the collaboration phase of the process will begin. The goals of the collaboration phase are to:

  • Create a mutual understanding of the target technology profile including the important risks and benefits.
  • Discuss the development of the technology or potential regulatory pathways going forward.

The FDA will work closely with the participants selected for the challenges. The regulatory standard of demonstrating a reasonable assurance of safety and effectiveness still applies. Review of these challenge submissions does not constitute regulatory acceptance or endorsement of a process associated with a premarket submission. These methods or technologies would still have to be reviewed through the relevant premarket pathway.

For applicants who were not selected, the standard mechanisms for interaction with the FDA's Center for Devices and Radiological Health (CDRH) are available. These sponsors have been encouraged to interact with the agency through the Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov. DICE will assist in answering questions on U.S. medical device regulation or to direct sponsors to the appropriate premarket review division.

Goal of this Challenge: Identify Sterilization Alternatives

In response to the February 2019 closure of a large device sterilization facility, the FDA is taking steps to ensure that hospitals, health care providers, and patients have access to medical devices that are safely and effectively sterilized.

The goal of this challenge is to identify safe and effective sterilization methods or technologies for medical devices that do not rely on ethylene oxide and that meet these criteria:

  • Compatibility: The method or technology should be compatible with a large cross -section of materials used to manufacture or fabricate medical devices as well as packaging materials or sterile barriers. The materials, devices and barriers of particular interest are those that are compatible with ethylene oxide sterilization.
  • Scalability and High Throughput: The method or technology should have the potential to be scalable and allow for the effective sterilization of large volumes of devices.

Basic Criteria for Challenge Submissions

The challenge submissions were expected to succinctly describe:

  • Anticipated benefit of the technology or method
  • Impact of the method or technology on public health as compared to other available alternatives
  • Compatibility of the method or technology with medical device materials
  • Capability of the method or technology to ensure scalability and high throughput for safe and effective sterilization of large volumes of devices

The FDA also considered factors such as:

  • Feasibility of the strategy or technology
  • Impact of the FDA's involvement

Elements that would have been considered within this challenge scope:

  • Methods that can sterilize a wide range of polymeric materials without changing the chemical and physical properties of the polymers by degrading them (e.g., through oxidization, chain scission, or other unfavorable reactions) or by generating unacceptable levels of toxic by-products such as leachables.
  • Materials or medical devices that are typically sterilized by ethylene oxide.
  • Methods that can or have potential to sterilize bulk volumes/large loads of products
  • Methods that employ the use of technologies and infrastructure that is readily accessible or rapidly developed to medical device manufacturers and sterilization providers in the United States.

For more information

If you have questions about this challenge, email CDRH-Innovation-Sterilization@fda.hhs.gov.