H.R. 3303, the ‘‘Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013’’

H.R. 3303, as introduced by Rep. Marsha Blackburn (R-TN), would create a newly defined category of “medical software” that is not a medical device but would require FDA to continue to regulate the "medical software" like devices.  The bill also would remove FDA’s jurisdiction over a newly defined category of “clinical software” and “health software.”