For low risk medical devices, startups can use a FDA 510(k) [0] to get approval if the device has a comparable (predicate) device already approved. This is how

For low risk medical devices, startups can use a FDA 510(k) [0] to get approval if the device has a comparable (predicate) device already approved. This is how some startups get devices approved with relatively little red tape from the FDA. This may also work for some healthcare software apps. [0] http://www.emergogroup.com/resources/articles/fda-510k-clearance-process http://www.emergogroup.com/resources/articles/fda-510k-clear...