A new guidance was released this month by the FDA detailing risk-benefit determinations in de novo Process and Premarket Approvals (PMAs) for medical devices. According to the FDA, the guidance fittingly titled: “Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” is intended to provide greater clarity on the FDA’s decision making process with regard to assessing the probable benefit of a device versus its probable risk.