FDA has released the draft guidance Software as a Medical Device (SaMD): Clinical Evaluation with the intention of “establishing the scientific validity, clinical performance, and analytical validity for a SaMD,” according to an agency release. The draft aims to provide globally harmonized, risk-based principles of when and what type of clinical evaluation is appropriate for an SaMD, according to FDA.
“Global regulators expect that clinical evaluation and the evidence generated for a SaMD have the same scientific level of rigor that bis commensurate with the risk and impact of the SaMD, to demonstrate assurance of safety, effectiveness and performance. SaMD however is unique in that it operates in a complex highly connected-interactive socio-technical environment in which frequent changes and modifications can be implemented more quickly and efficiently. Development of SaMD is also heavily influenced by new entrants unfamiliar with medical device regulations and terminology developing a broad spectrum of applications.” – SaMD: Clinical Evaluation guidance document excerpt
The 46-page document was put together with the guidance of the International Medical Device Regulators Forum (IMDRF). The Federal Register will receive comments on the draft for the next 60 days.