Federal regulatory frameworks governing medical products are designed to (1) provide evidence that a product benefits patients when used as intended and should be available despite accompanying risks and (2) ensure timely access to needed therapies and diagnostics. Historically, policy makers and product developers have viewed these objectives as being in tension. However, ensuring safety, expediting patient access, and enabling innovation can be complementary goals within a regulatory framework for medical devices.
Shuren J, Califf RM. Need for a National Evaluation System for Health Technology. JAMA. 2016;316(11):1153-1154. doi:10.1001/jama.2016.8708