FDA Issues Draft Guidance on Software as Medical Device

摘要

The US Food & Drug Administration (FDA) released draft guidance developed by the International Medical Device Regulators Forum (IMDRF) that aimed to establish a common understanding of clinical evaluation and principles for demonstrating the safety, effectiveness, and performance of software intended for medical purposes as defined in the IMDRF/SaMD WG/NK) document Software as a Medical Device (SaMD): Key Definitions 46 (SaMD N10). The draft guidance stated that for all medical devices, clinical evaluation-a process activity that is conducted during a product's lifecycle as part of the quality management system-is the assessment and analysis of clinical data pertaining to a medical device to verify its safety, effectiveness, and performance. The FDA guidance also stated that SaMD, a type of medical device, has significant patient and public health impact and therefore requires reasonable assurance of safety, effectiveness, and performance.