June 12, 2017

FDA releases list of reusable devices requiring new validated IFU, validation data

By: Judy Mathias

Editor’s Note

The Food and Drug Administration (FDA) on June 9 released a list of reusable devices that will require new validated instructions for use (IFU) and validation data in premarket notifications regarding cleaning, disinfection, and sterilization. These actions are effective August 8, 2017.

The list includes:

  • Bronchoscopes (flexible or rigid) and accessories
  • Ear, nose, and throat (ENT) endoscopes and accessories
  • Gastroenterology and urology endoscopes that have elevator channels and other gastroenterology and urology endoscopes (not including accessories)
  • Automated reprocessors for reusable devices
  • Neurological endoscopes (not including accessories)
  • Water-based heater-cooler systems for use in operating rooms
  • System, surgical, computer controlled instrument
  • Arthroscopes and accessories
  • Laparoscopic instruments and accessories
  • Electrosurgical instruments and accessories.

The Food and Drug Administration (FDA or Agency) has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and…

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