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.
The approach is expected to last about three years.
EtO is used to sterilize almost half of the devices sold in the US but has been linked to an...