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FDA Issues Final EO Site Change GuidanceFDA Issues Final EO Site Change Guidance
The new transitional enforcement policy addresses urgent public health concerns related to ethylene oxide (EO) sterilization and potential sterile medical device shortages.
3 Min Read
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At a Glance
- FDA’s guidance aims to mitigate medical device shortages during EO sterilization facility transitions for Class III devices.
- Manufacturers must notify FDA of site changes; guidance outlines steps for exercising enforcement discretion in transitions.
- FDA supports flexibility during compliance shifts to EPA’s emission standards, ensuring patient access to essential devices.
The US Food and Drug Administration recently announced the availability of a final guidance titled “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices.” The guidance provides information and recommendations to holders of premarket approval applications (PMAs) and humanitarian device exemptions (HDE) for Class III devices sterilized by EO and affected by operation reductions at sterilization facilities.
During the final Medical Device Sterilization town hall for 2024 on December 4, panelists from FDA discussed the guidance and its implications at length. According to the agency, the guidance was developed to prevent or mitigate a potential risk of supply chain disruptions for medical device shortages while manufacturers are transitioning to compliance with the Environmental Protection Agency’s amended National Emissions Standards for Hazardous Air Pollutants (NESHAP).
The guidance provides an enforcement discretion policy to respond to anticipated changes in EO sterilization activities as facilities work to implement EPA’s rule. FDA anticipates that some EO sterilization facilities will need to install emissions controls or make changes to their operations as they prepare to comply, which could involve temporarily reducing or relocating sterilization operations during this transition.
What is the enforcement discretion policy?
Per FDA, the enforcement policy outlines the general framework for the agency to determine, on a case by case basis, whether the exercise of enforcement discretion related to the sterilization of Class III devices at a proposed new sterilization location — and subsequent distribution of such devices prior to approval of a PMA or HDE site change supplement — is appropriate.
Device manufacturers interested in having FDA consider the exercise of enforcement discretion should submit an informal notification to FDA, as recommended in Section 5 of the guidance. FDA will then evaluate the information and determine whether enforcement discretion is appropriate. If it is, the manufacturer should begin preparing a PMA 180-day site change supplement or an HDE 75-day site change supplement for FDA submission within 120 calendar days from the date of correspondence.
If the exercise of enforcement discretion is not appropriate, a PMA or HDE holder may still submit a site change supplement, but it will be reviewed according to the normal timeline for that type of supplement.
What should manufacturers include in their notification?
FDA recommends the following sterilization-related information, as outlined in Section 5C of the guidance, to identify the specific sterilization sites that are affected and evaluate the potential impacts of the notification:
• The name, address, and FDA Establishment Identification (FEI) number of the facility and proposed new or additional sterilization sites.
• Identification of whether the proposed sterilization sites were previously cleared under the original PMA or HDE, or a PMA or HDE supplement.
• Identification of whether current and proposed alternate/additional sterilization sites are ready for FDA inspection, if applicable.
• The date on which the site change will be implemented.
• A brief summary of any changes to the sterilization process that may result from the site change.
FDA also recommends the notification include a statement of affirmation signed by a responsible person of the firm who is required to submit the PMA.
The new guidance is being issued without prior public comment, but it remains subject to comment in accordance with the agency’s good guidance practices. You may submit electronic comments and suggestions at any time for agency consideration to www.regulations.gov. Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852- 1740. Identify all comments with the docket number FDA-2024-D-2274.
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