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Does anyone know whether a new research application (non-510k approved use) of a software medical device can be placed in an existing 510k approved product?
2 min reading time
As originally asked by Stuart Swibel.
We have a new application that uses most of the same algorithms contained in our existing 510K approved product although this particular application use is not covered in our original 510k filing. Ideally, we would like to provide the new application protocols on a version of our existing device (which is software that runs on standard PC) for investigational research purposes (a quid pro quo since it may help with our product development). The question is whether all the screen labels and other references pertaining to the name of the 510k approved product need to be removed from this version before being provided to the investigational research site? I assume that we will need to have a pop-up window or physically label the equipment with a research only use disclaimer. I’d appreciate any advice anyone has on this subject. Thank you.
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