On Dec. 8, 2017, the FDA released the final guidance, “Software as a Medical Device (SAMD): Clinical Evaluation.” The October 14, 2016, draft is now obsolete. This guidance is actually the use of an International Medical Device Regulators Forum (IMDRF) document completed in June of 2017, so this represents broad international consensus. This guidance discusses various types of clinical evidence to support safety and effectiveness of a wide range of software devices. Information is provided on the FDA’s perspective on use of pre-existing scientific and clinical information, analytical evaluation, and bench testing. It also distinguishes between expectations for well-established clinical associations vs. novel clinical associations. Section 9.0 discusses Continuous Leveraging of Real World Performance Data to support additional performance claims and functions or to reduce such claims. The full guidance is at the link provided. PDF Copy of FDA Guidance
