Draft Bill Shows Congress' Struggle To Define FDA's Role In Medical Software

A discussion draft of Rep. Marsha Blackburn's (R-TN) planned bipartisan bill attempts to draw a sharp line between “medical” software that would fall under FDA's jurisdiction and “health” that would not, but lawmakers are still grappling with how to ensure that software intended to be regulated is not accidentally exempted. The draft bill , obtained by Inside Health Policy , flags areas that still need to be worked out, but a lobbyist following the issue says the latest approach is...