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Focus on Regulation

FDA Requires Reprocessing Validation Data for Certain Reusable Devices

On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated instructions for use and reprocessing instructions addressing  cleaning, disinfection, and sterilization.  Although the Notice was required by Section 3059 of the 21st Century Cures Act, it is consistent with FDA’s recent focus on reprocessing activities in response to public health concerns raised by inadequate reprocessing of reusable medical devices.

The Notice identifies a  list of devices for which validated reprocessing will now be required for 510(k) notices submitted after August 8, 2017, noting that the listed devices and their accessories have specific design features such as crevices, irregular surfaces, dead-end chambers, sleeves, and other features that make them more challenging to adequately reprocess between uses.   The list of devices includes:

  • Bronchoscopes (flexible or rigid) and accessories;
  • Ear, Nose, and Throat (ENT) endoscopes and accessories;
  • Gastroenterology and Urology Endoscopes that have elevator channels (not including accessories) [e.g., duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP)];
  • Automated Reprocessors for Reusable Devices;
  • Other Flexible Gastroenterology and Urology Endoscopes (not including accessories);
  • 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; and
  • Electrosurgical instruments and accessories.

510(k) notices for the above-listed medical devices will not be substantially equivalent if the validated instructions for use and reprocessing validation data (e.g., data regarding cleaning, disinfection, and sterilization) are not provided or are inadequate.  Device sponsors should consult FDA’s 2015 guidance, Reprocessing Medical Devices in Health Care Settings:  Validation Methods and Labeling, for information on the reprocessing validation methods necessary to support a finding of substantial equivalence for these devices going forward.