New Article Now Available on the Life Sciences Industry Blog - Rewriting Approval: The FDA's Emerging Framework for Faster Access to Therapies

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Preventing Medical Device Shortages Through Improving the United States Sterilization Supply Chain

A surgeon handles sterilized medical equipment

Both Ethylene Oxide (EtO) and gamma radiation are highly effective sterilizers for medical devices, but they face significant supply chain vulnerabilities that have already led to shortages within the United States. To mitigate these risks and bolster the sterilization supply chain, the FDA recently approved a new “Established Category A” sterilization method and implemented three key programs designed to encourage medical device manufacturers to adopt alternative methods, all within the last five years (FDA, 2024).


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