Three top Democratic Senators on the US Senate Health, Energy, Labor and Pensions Committee (HELP) want answers on US FDA's planned pre-certification program; they've sent Commissioner Gottlieb an extensive list of questions on the subject. The lawmakers are concerned the agency may be moving forward without proper statutory authority and are concerned the program may not provide the oversight needed to ensure medical software products meet the agency's level of safety and efficacy.
The agency has been developing the program, which remains in a pilot phase, for about the past two years