• RF Quarterly

    The evolution of the De Novo pathway

    This article provides an overview of the regulatory history of the De Novo pathway, from its initial introduction in the Food and Drug Administration Modernization Act (FDAMA) in 1997 to its Final Rule implementation into the US Federal Regulation via 21 CFR 860 in 2022. The authors provide a summary of each of the establishing acts and guidances that have culminated in the regulation, emphasize the historic changes of the process, and provide an analysis of the impact of ...
  • RF Quarterly

    Overcoming obstacles for SaMD development

    This article provides an overview of the quality system requirements concerning software as a medical device (SaMD), with an emphasis on learnings and considerations for implementing an agile or hybrid-based development process. The authors further expand upon topics unique to SaMD development, specifically the importance of dataset integrity during development, considerations for proactive postmarket surveillance and the interplay between cybersecurity and risk management...