Zdrowie i gospodarka · 26/11/2019

FDA Announces Ethylene Oxide Sterilization Master File Pilot Program to Enhance Patient Safety and Environmental Sustainability

The US Food and Drug Administration (FDA) is launching a voluntary pilot program to streamline the sterilization process for single-use medical devices, allowing companies to submit a Master File when making changes to their sterilization processes, and potentially referencing this file in postapproval reports instead of submitting a new premarket approval application.