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FDA Reveals list of Devices Requiring Reprocessing Validation

June 9, 2017

The U.S. FDA, has released a list of reusable devices that must provide validation data for the device's instructions for use (IFUs) and validation data in their 510(k) premarket notifications submissions.  Dated Friday June 9, 2017, this list includes devices that have a risk of spreading infection if not cleaned properly and design features on those devices that make the proper cleaning, disinfection and sterilization challenging.  The requirements are effective August 8, 2017.

UL offers medical device testing to internationally harmonized standards and other test methodologies that can support validation requirements for FDA submissions. Find out more at: https://industries.ul.com/medical-and-laboratory/medical-device-testing-services/validation-of-cleaning-reprocessing-and-sterilization-iso-17664

UL HFE experts can also provide usability testing and summative testing on the potential for use-errors with IFUs that can be used to support FDA submissions.  Find out more:  https://industries.ul.com/medical-and-laboratory/medical-devices/hfe

Link to the Notice:  https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/html/2017-12007.htm

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