Tuesday, January 27, 2015

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

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