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FDA turn down NDA with concerns relating to device use safety and human factors data
The FDA have turned down Titan Pharmaceutical’s Probuphine subdermal implant NDA in its current form. Along with other requests, they have asked for additional human factors data on the training associated with the implant’s insertion and removal.
This is the latest evidence of the FDA’s increased concern over the usability of medical devices and the quality of human factors data provided as part of an NDA.
All of us working in the HFE/usability field continue to pay careful attention as the industry and regulator work towards a shared understanding of acceptable medical device usability and how this should be demonstrated and justified.
I will be presenting on human factors engineering (HFE) of combination products at IBC’s Human Factors for Drug-Device Combination Products conference in Bethesda on May 14th and 15th and at Respiratory Drug Delivery (RDD) 2013 in Berlin the following week.