Enforcement Discretion Can Help With EtO Sterilization Limits

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Enforcement Discretion Policy Can Help Device Firms Facing Potential EtO Sterilization Restrictions

Dennis Tosh

November 26, 2024 at 05:31 PM EST

The FDA has released a transitional enforcement discretion policy for manufacturers of certain Class III devices that provides recommendations on how they can respond to anticipated restrictions on ethylene oxide (EtO) sterilization of their products. The guidance — “Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices” — “he... Read More

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Enforcement Discretion Policy Can Help Device Firms Facing Potential EtO Sterilization Restrictions

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