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The U.S. Food and Drug Administration has adopted an international sterilization standard to give medical device manufacturers another alternative to ethylene oxide (EtO).
Manufacturers can now make declarations of conformity to the International Organization for Standardization’s recommendations on low-temperature vaporized hydrogen peroxide in submissions to the FDA.
The FDA framed the addition of the ISO test to its Recognized Consensus Standards database as a response to pressure to reduce EtO use and the need to support supply chain resiliency.