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FDA Innovation Challenge 1: Identify Sterilization Alternatives

On a mission to identify safe and effective sterilization methods or technologies for medical devices that do not rely on ethylene oxide.
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Summary

Overview

FDA Innovation Challenge 1: Identify New Sterilization Methods and Technologies

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.   

 

 


Guidelines

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

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 .

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

Contact Us

If you have questions about this challenge, email .

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