FDA has released a list of reusable device types that will require validated instructions for use and validation data regarding cleaning, disinfection, and sterilization in their 510K submissions.
The notice is from the Federal Register dated June 9, 2017.
To view the FDA’s list of reusable devices types (PDF): FDA-Table1-ReusableDevices
To view the FDA’s list of design features that may pose a challenge (PDF): FDA-Table2-DesignFeatures
How can WuXi AppTec help?
WuXi AppTec has more than 25 years of experience and a proven track record of success with reprocessing validations for more than 1500 devices.
Partner with the Experts!
Let our team work with you to develop a customized approach for your reusable device that meets the latest regulatory expectations.
Click here for more information about our reprocessing validation services.
To learn more about how the FDA’s notice on reusable devices may affect you and the comprehensive services WuXi AppTec can provide, contact us at firstname.lastname@example.org