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FDA DRAFT GUIDANCE ON PROCESSING/REPROCESSING MEDICAL DEVICES

Download and learn what the FDA is saying about the Processing & Reprocessing of Medical Devices. This document is a compilation of the organization’s latest recommendations and guidelines regarding the Processing / Reprocessing of Reusable Medical Devices in Healthcare Settings, focusing on Validation Methods and Labeling.  What you can expect to find inside: 

  • FDA’s 7 Criteria for Reprocessing Instructions
  • FDA’s latest recommendations on Validation of Reprocessing Methods
  • Typical Sterilization Cycles for Steam Sterilization & EO Sterilization
  • FDA’s recommendations on labeling of Reusable devices
  • Detailed Reprocessing Overview Flowcharts

Once approved this draft will form FDA’s official policy on Processing and Reprocessing of Medical Devices.  So obtain it now to stay updated and prepared.

Download the Guidance Now

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