The FDA has issued a final guidance titled “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices.” This guidance outlines the agency’s policy regarding sterilization site changes for Class III medical devices sterilized using ethylene oxide (EtO). It is intended to address potential or actual disruptions at sterilization facilities that may affect the availability of sterile medical devices. The policy allows device manufacturers to temporarily transition sterilization to alternative facilities before submitting a premarket approval (PMA) or humanitarian device exemption (HDE) site change supplement, provided they adhere to the recommendations in the guidance.
The guidance specifies the information manufacturers should submit when notifying the FDA of a sterilization site change conducted under this policy. This approach is designed to minimize disruptions in the supply chain and mitigate potential shortages of sterile medical devices. By providing clarity on the regulatory framework, the FDA aims to enable manufacturers to proactively secure alternative sterilization sites while maintaining compliance with regulatory requirements. The enforcement discretion policy addresses urgent public health concerns by supporting timely and effective transitions to new sterilization sites. The guidance emphasizes the importance of managing changes in manufacturing sites, including adjustments to processes, methods, procedures, qualifications, and validations, to maintain an adequate supply of sterile devices. FDA is issuing this guidance in response to these anticipated changes in sterilization operations, helping to prevent or mitigate the potential risk of medical device supply chain disruptions or shortages.
Read the full guidance here.
