Ethylene oxide: FDA issues enforcement discretion policy for sterilization site changes

In an effort to minimize supply interruptions for class III medical devices that are sterilized using ethylene oxide (EtO), the US Food and Drug Administration (FDA) announced a temporary enforcement policy to enable certain sterilization site changes to take place following an “informal notification” to the agency.

The enforcement policy comes after the Environmental Protection Agency’s (EPA) final rule issued in March 2024, which amends the National Emission Standards for Hazardous Air Pollutants (NESHAP) to restrict the use of EtO. (RELATED: EPA finalizes rule to reduce EtO emissions from sterilization facilities, Regulatory Focus 14 March 2024).

This policy applies to holders of approved premarket approval (PMA) or humanitarian device exemptions (HDEs) for class III devices sterilized by EtO that are impacted by the EPA policy. Such devices would typically require the submission of a 180-day PMA site change supplement or 75-day HDE site change supplement for switches to a new sterilization site.

The discretion aims to “prevent and mitigate potential concerns with medical device availability that may result from changes in sterilization operations during the time period in which manufacturers are transitioning to compliance with new requirements,” said FDA.

FDA said that more than 20 billion devices sold in the US every year are sterilized with EtO, and account for approximately 50 percent of devices that require sterilization.

The guidance notes that some EtO sterilization facilities will need to install new controls or make changes to their operations to comply with EPA’s final rule. FDA notes that some facilities “may either reduce their sterilization operations or seek to change the location of their sterilization operations during this period of transition.” EPA set 6 April 2026 as the compliance deadline for its EtO final rule.

FDA recommends that affected device manufacturers who are requesting enforcement discretion submit an “informal notification” with the following information:

The name of the device and the associated product code, the PMA or HDE number for the device;
The sponsor’s name, address, and contact information, including an email address, and phone number;
The reason for the notification;
The name, address, and FDA Establishment Identification (FEI) number of the sterilization site;
The proposed new or additional site where sterilization will take place, including the name, address, and FEI number of the facility;
Identifying whether the proposed sterilization site was previously approved under a original PMA or HDE or a PMA or HDE supplement;
Identifying whether the current or proposed alternate sterilization sites are ready for FDA inspection.

FDA said it will grant such discretion will be given on a case-by-case basis.

The guidance is being implemented without prior public comment. FDA has determined that “prior public participation for this guidance is not feasible or appropriate.”

Earlier this year, FDA recategorized vaporized hydrogen peroxide (VhP) as a sterilization agent to demonstrate to medical device manufacturers that it has confidence in the agent’s ability to sterilize medical devices and is a good alternative to EtO. (RELATED: FDA updates sterilization category to encourage vaporized hydrogen peroxide use, Regulatory focus 8 January 2024.)

In August 2022, EPA released an analysis that showed the EtO emissions from some commercial sterilizers in the US contribute to elevated cancer risk for people living in nearby communities and announced plans to publish an air pollution rule by the year’s end. (RELATED: EPA lists potentially high-risk EtO plants, plans to finally publish air pollution rule by year’s end, Regulatory Focus 3 August 2022)

Federal Register notice, Guidance

Ethylene oxide: FDA issues enforcement discretion policy for sterilization site changes

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