HR 3303: Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013
Rep. Marsha Blackburn (R-TN)’s HR 3303 would divide health-related software into three categories, define ‘medical software’ versus ‘clinical software’ or ‘health software,’ and place medical software under FDA regulation. The FDA currently regulates ‘devices,’ which this bill differentiates from software, but all provisions that apply to devices would also apply to medical software under this bill.