Who owns the 510(k)?
@article{Donawa2008WhoOT,
title={Who owns the 510(k)?},
author={M. Donawa},
journal={Medical device technology},
year={2008},
volume={19 2},
pages={
26, 28-9
}
}Unfortunately, some medical device manufacturers, particularly those based outside the United States (US) are unaware of the business implications of submitting a 510(k) premarket notification to the US Food and Drug Administration. This article discusses information regarding the ownership and other business related aspects of filing a 510(k).