A blog about important topics for medical device and healthcare innovators.
By Pamela Davol, Clinical & Regulatory Project Manager
A recent discussion in an online industry group posed the question, Is Usability Research Necessary for your FDA Submission?
The reply was as follows-
There should no longer be a debate or even a question as to whether or not usability studies are required for a regulatory submission of a medical device or product containing a medical device constituent (i.e. combination product with device-delivery system): a manufacturer will not get a new device or combination product with device clearance/approval without usability testing; and even some manufacturers who are making changes to previously cleared/approved devices are being asked to conduct usability testing based on changes to the design-user interface of predicate devices.
Wherever you are in your process, Ximedica can help.
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Ximedica is ISO 13485:2012 Certified and FDA Registered. As a full-service development firm, Ximedica has an exclusive focus on medical products and over 25 years of experience developing medical devices, combination products and consumer healthcare products.
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