lunes, 15 de julio de 2019

Device Shortages Update: The FDA Announces Two New Innovation Challenges on Device Sterilization



Device Shortages Update: The FDA Announces Two New Innovation Challenges on Device Sterilization

The U.S. Food and Drug Administration (FDA) is announcing two Innovation Challenges to encourage the development of new approaches to device sterilization. The challenge submission period begins July 15 and ends October 15.

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.

FDA Innovation Challenge 2: Reduce Ethylene Oxide Emissions

The goal of this challenge is to develop strategies or technologies to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process.

For More Information

  • Webinar: On Tuesday, August 13, 2019, the FDA will sponsor a webinar on the challenges, including details on submission requirements and what to expect if you participate in a challenge.
  • Contact for the challenges: If you have questions about the challenges, email CDRH-Innovation-Sterilization@fda.hhs.gov .

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