The FDA’s Breakthrough Devices Program is for certain medical devices that provide treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.1 This particular pathway is reserved for devices with unique and other-wise unavailable treatments to serious conditions, but what about devices associated with conditions less serious than those eligible for the Breakthrough Devices Program? The answer to this question is the FDA’s Safer Technologies Program or STeP. STeP is targeted at medical devices that treat or diagnose conditions that are milder than what is eligible for the Breakthrough Devices Program, and even includes conditions that are non-life-threatening or reasonably reversible.2 There are two eligibility factors for STeP...