518-Raising the Bar: New Standards for IFU Development

Developing and validating the instructions for use (IFU) for processing (cleaning, disinfecting and/or sterilizing) medical devices by a healthcare facility is a significant responsibility of medical device manufacturers (MDMs). The U.S. Food and Drug Administration (FDA) requires that these instructions be validated—not just for efficacy but also so the healthcare facility can practically implement the instructions.

This lesson is set to expire June 30, 2024.


  1. Click the "Handouts" tab to download and read the Lesson Plan
  2. Click the "Contents" tab to begin the Quiz
Components visible upon registration.