The agency allows companies to apply for ‘de novo’ status if the device represents an improvement on an already approved device. The bill would allow devices that pose low or moderate safety risks but have no precedent to apply for ‘de novo’ status without a 510(k) application. Sen. Brown has been a strong opponent of the medical device tax since his election.
Related Articles on Medical Devices:
CMS Targets Unnecessary Medical Technology, Devices
Global Medical Device Market Will Reach $350B by 2016
Qualcomm Launches Medical Devices Subsidiary Backed by $100M Fund
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