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

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices." This guidance provides information regarding FDA recommendations and general principles to be referenced by holders of premarket approval applications (PMAs) and humanitarian device exemptions (HDE) for class III devices sterilized by ethylene oxide (EtO) whose products are affected by the potential, actual, or temporary stop or reduction of operations at a sterilization facility, if they wish to have FDA consider whether the exercise of enforcement discretion relating to the implementation of certain types of sterilization site changes is appropriate. FDA is issuing this guidance to provide an enforcement discretion policy to help proactively address manufacturing limitations or supply chain issues due to disruptions caused by closures or potential closures of sterilization facilities that use EtO as a medical device sterilant during the time in which manufacturers are transitioning to compliance with certain new requirements. FDA believes that the enforcement discretion policy described in this guidance may help address concerns during this time related to potential sterile medical device impacts affecting certain devices sterilized by EtO, help mitigate possible interruptions in sterile device processing, and help maintain adequate supplies of finished sterile medical devices. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.