Reusable medical devices are devices that health care providers can reprocess and reuse on multiple patients. These reusable devices represent a large percentage of today’s new product development and submissions to the US FDA. Understanding and mastering the FDA's Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling is the first step in getting new, reusable devices into the US marketplace. This FDA guidance document outlines general considerations of the design and safety of all reusable medical devices as well as what’s important to include in the development and validation of reprocessing instructions for users to follow.
In this presentation, an expert will review and discuss the key points of this document, provide useful tips for managing new validation studies and offer insight into the development and validation process to help accelerate the time to market approval. Avoiding costly FDA deficiencies is challenging; this course will help manufacturers get it right the first time.
Key Topics will Include:
Useful tips for developing validation studies that are accepted on the first submission
How to properly classify your device for reprocessing
Understanding FDA’s six criteria for reprocessing instructions
Understanding cleaning, disinfection, and sterilization – the differences between them and how they should be applied to products based on classification
Useful tips on developing Instructions for Use to minimize human error or confusion