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FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies

FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies

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

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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.   

Timeline and Deadlines

Solutions must be submitted to CDRH-Innovation-Sterilization@fda.hhs.gov by 12:00 PM Eastern time on October 15, 2019.

  • Challenge begins: July 15, 2019
  • Submission period: July 15, 2019 - October 15, 2019
  • Judging period: October 16, 2019 - November 16, 2019

The FDA intends to announce applications selected for this challenge in December 2019. As many meritorious applications as resources permit will be selected. Following completion of the review, applicants will be notified of their application status.

The FDA will obtain consent from selected applicants before publicly disclosing any proprietary information contained in their application.

Selected applicants will work with the FDA to accelerate the development and review of technology.

Challenge Participants

The FDA encourages participation in this challenge from organizations such as:

  • Sterilization companies
  • Medical device companies or distributors
  • Technology manufacturers (including start-up companies or labs)
  • Academic and research institutions
  • Healthcare facilities
  • Professional societies
  • Foundations and other non-profits

Basic Criteria for Challenge Submissions

The challenge submissions should 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 will also consider factors such as:

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

Elements that would be 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 US

Application Format

Applications should be no longer than 20 pages using Times New Roman, 12-point font. All content should be written in English, converted to PDF format, and emailed to CDRH-Innovation-Sterilization@fda.hhs.gov.

Cover Page

  1. Company name, address, name of a contact person including their phone number and email address.
  2. Name of alternative sterilization method or technology.
  3. FDA regulatory history, if appropriate.
  4. The name of the challenge: Challenge 1: Identify New Sterilization Methods and Technologies.
    Note: If your challenge submission involves ethylene oxide in any way (sterilization, mitigation, etc.), your submission should be directed to Challenge 2.

Executive Summary (limit to 1 page)

  1. A summary of what the method or technology is intended to do.
  2. The significance of the problem it will solve.
  3. A summary of the proposed development plan.

Proposal: Should address all the following topics:

  • The development plan for the method or technology
  • The development team (including names of essential team members and prior experience of each team member in sterilization methods or technologies)
  • The scientific basis and/or preliminary data supporting the proposed method or technology
  • 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

For more information

On Tuesday, August 13, 2019, the FDA sponsored a webinar on the challenges, including details on submission requirements and what to expect if you participate in a challenge. View webinar materials.

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