Innovative procedures and technologies are regularly introduced into clinical practice. Although the US Food and Drug Administration (FDA) exercises strict regulatory control over new drugs, it exerts minimal oversight for new devices and no oversight for new surgical techniques. When technology such as the da Vinci robot enters the field of surgery, it is less clear who is responsible for ensuring its safe introduction.

When implementing new technologies, physicians are guided by their sense of professionalism and the potential liability for medical malpractice; hospitals jointly share the medicolegal risks by confirming the qualifications of licensed physicians (credentialing) and by authorizing those physicians for specific patient care services (privileging). In recent years, controversy has arisen when manufacturers go beyond their traditional role (ie, to reasonably design and manufacture a device) and participate in training and credentialing physicians to use their company’s product. This Viewpoint reviews an important legal ruling on robotic surgery that highlights potential safety concerns regarding the regulation of novel procedures and technologies as they enter clinical practice.