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FDA Allows Some Sterilization Site Changes to Combat Device Shortages

 
• By Elizabeth Orr

A new FDA guidance addresses concerns about device shortages due to ethylene oxide (EtO) restrictions by allowing manufacturers of class III devices to switch sterilization sites before filing a PMA or HDE, helping to prevent supply chain disruptions and ensuring timely device sterilization.

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• Source: Shutterstock

New guidance from the US Food and Drug Administration may help allay some fears of device shortages caused by new restrictions on the use of ethylene oxide (EtO).

Key Takeaways

The enforcement discretion approach applies to class III devices that otherwise might be in short supply.

Eligible sponsors can change their device sterilization site by emailing the agency with product details and information about the new proposed site

EtO is used to sterilize almost half of the devices sold in the US but has been linked to an increased risk of cancer. In March, the Environmental Protection Agency (EPA) finalized a rule that will ultimately cut EtO emissions by about 90%

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