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Abstract-The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the center within the agency that is responsible for pre-and postmarket regulation of medical devices. In this article, we review current regulation of medical devices, research and development programs, pre-and postmarket perspectives, and future considerations of medical devices, particularly as they relate to devices targeting acute ischemic stroke as an example of the process. We also review the Center for Devices and Radiological Health's historical perspective of acute ischemic stroke trials and clinical trial design considerations used in prior studies that have led to US market clearance as they are related to currently marketed devices indicated for acute ischemic stroke.

A long-standing theoretical debate concerns the involvement of principled reasoning versus relatively automatic intuitive-emotional processing in moral cognition. To address this, we investigated whether the mental models formed during story comprehension contain a moral dimension and whether this process is affected by cognitive load. A total of 72 participants read stories about fictional characters in a range of moral situations, such as a husband being tempted to commit adultery. Each story concluded with a “moral” or “immoral” target sentence. Consistent with a framework of efficient extraction of moral information, participants took significantly longer to read immoral than moral target sentences. Moreover, the magnitude of this effect was not compromised by cognitive load. Our findings provide evidence of efficient coding of moral dimensions during narrative comprehension and demonstrate that this process does not require cognitively intense forms of principled reasoning.