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GUIDANCE DOCUMENT

Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices Guidance for Industry and Food and Drug Administration Staff November 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2024-D-2274
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA is issuing this guidance to communicate its policy regarding sterilization site changes for ethylene oxide (EtO) sterilized PMA and HDE devices in situations where those devices are affected by the potential, actual, or temporary operation reductions at sterilization facilities that may affect the availability of those sterile medical devices. FDA does not intend to object to sterilization of Class III devices at a proposed new location and subsequent distribution prior to submission of a PMA or HDE site change supplement when site changes are performed consistent with recommendations described in this guidance. The guidance describes information device manufacturers may provide when notifying the Agency of a sterilization facility site change that will be conducted according to the policy in the guidance. FDA believes that the policy set forth in this guidance may help prevent or mitigate the potential risk of supply chain disruptions or sterile medical device shortages by clarifying the regulatory landscape for devices sterilized by EtO and helping device manufacturers to quickly and proactively secure alternative locations for the EtO sterilization of devices. 

This guidance is intended to provide information regarding a voluntary alternative regulatory approach for sterilization site changes specifically for PMA and HDE holders of approved Class III devices sterilized by EtO. It does not apply to other changes for which an applicant may submit a PMA or HDE supplement if the changes affect the safety or effectiveness of the device. It does not apply to combination products, devices sterilized by methods other than EtO, or changes in sterilization methods from EtO to a method using a different sterilant. The alternative approach described in this guidance does not affect the policy described in the guidance document, “Manufacturing Site Change Supplements: Content and Submission”, and it is not meant to supersede that guidance. It is intended to facilitate a different timeline and process for assisting device manufacturers to quickly secure alternative sterilization facilities in cases where a potential change in the availability of EtO sterilization capacity may result in a sterile medical device shortage.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-2274.

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