Proposed Bill Would Prevent FDA Regulation of Some Apps

A bipartisan group of lawmakers is proposing legislation that would block the FDA from regulating any medical apps that fall outside a narrow definition of “medical software.” The Sensible Oversight for Technology Which Advances Regulatory Efficiency (SOFTWARE) Act, H.R.3303, was introduced Tuesday by Rep. Marsha Blackburn (R-Tenn.) and cosponsored by Reps. Gene Green (D-Texas), Diana DeGette (D-Colo.), Greg Walden (R-Ore.) and G.K. Butterfield (D-N.C.).
Devices & Diagnostics Letter