FDA Addresses Development of Reprocessing Instructions for Reusable Medical Devices

March 18, 2015 | Strategic Insights for Health System


The U.S. Food and Drug Administration (FDA) has issued new guidance to help device manufacturers formulate and scientifically validate reprocessing instructions for reusable medical devices. Originally issued for public comments on May 2, 2011, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling addresses general considerations for the design of medical devices to facilitate easy and effective cleaning, discusses human factors in developing reprocessing instructions, and provides resources to aid the development of instructions, validation tests, and documentation for premarket submissions.

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