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    RF Quarterly

    RF Quarterly, April 2022: Software as a medical device

    Welcome to the April issue of RF Quarterly in which global experts on software as a medical device (SaMD) address software development and the associated challenges, clinical evaluation of SaMD, safety and security risk management, digital therapeutics, and more.   I thank the authors for their generosity in sharing their knowledge and expertise with the RAPS regulatory community and hope their articles and will serve as useful guidance and resources in your work. ...
  • RF Quarterly

    Software development

    This article applies to software development and validation and discusses the security and usability engineering aspects of software. It uses the term “software” for software as a medical device (SaMD) and medical device software (MDSW), including MDSW that is embedded on, drives, or influences the use of a hardware medical device, software accessories, and software components.  Keywords ‒ agile, development, incremental, software, static, waterfall   Standards an...
  • 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...
  • RF Quarterly

    Clinical evaluation of software

    Software has become an increasingly critical area of healthcare product development. Rapid technological advancement has resulted in substantial changes to software function and acceptance, leading to a growing number of novel medical devices capable of informing, driving, or replacing clinical choices, or directly providing therapy. Regulatory authorities expect that clinical evidence for a software as medical device (SaMD) is generated with a scientific level of rigor th...
  • RF Quarterly

    Safety risk management of software

    This article gives a background to the specific issues of dealing with risk management for software as a medical device. It makes many references to IEC 62304 and ISO 14971, the internationally recognized standards for medical software lifecycle and risk management, respectively. The authors elaborate on the most important challenges and propose strategies for managing them. They also examine other safety-critical industries and list a few methods to improve software quali...
  • RF Quarterly

    Security risk management

    Risk management is focusing increasingly on cybersecurity related ri sks, which can have an impact on human health, environment, and property. With the increasing threats of cyberattacks on the critical infrastructures, including healthcare, the need for secure products and services is becoming more prominent. Recent global development in which cyberwarfare has become a major issue further emphasize the need for good security management, as the chain is only as strong as...
  • RF Quarterly

    Digital therapeutics: Leveraging the SaMD framework for regulatory success

    The digital health sector is experiencing enormous growth globally. Briefly, digital health is a branch of healthcare that is primarily focused on improving health using internet, digital, and mobile technologies. One such novel subclass of the digital health ecosystem is digital therapeutics (DTx). DTx are “software-driven,” nonpharmacological therapeutic interventions that can improve the accessibility and effectiveness of healthcare. This article explores the current di...
  • Regulatory NewsRegulatory News

    Report: Using RWD to evaluate AI-enabled clinical decision support tools

    A new analysis from the Duke-Margolis Center for Health Policy outlines the data elements that real-world data (RWD) sources would need to capture in order to evaluate the performance of artificial intelligence (AI)-enabled clinical decision support tools, as well as the ongoing challenges related to data quality, privacy and security.   AI-enabled clinical decision support tools can be difficult to evaluate after deployment because of the non-standardized nature of el...
  • Feature ArticlesFeature Articles

    Artificial intelligence in regulatory practice

    This article will examine ways in which the regulatory profession can draw artificial intelligence (AI) to navigate the complexities and fluidity of the global regulatory landscape. Keywords – artificial intelligence, big data, machine learning, SaMD   Introduction Many of the processes within the regulatory landscape entail gathering data, tabulating spreadsheets, collating documents for regulatory submissions, and reviewing dossiers to ensure their quality is c...
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    FDA issues draft guidance for device software in premarket submissions

    The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about the documentation needed to support the agency’s evaluation of device software functions for premarket submissions.   The agency said the guidance recognizes the “rapidly evolving nature of digital health and recent FDA recognized consensus standards related to software” and, when finalized, will serve as an update to the Guidance for the Content of Premark...
  • Feature ArticlesFeature Articles

    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
  • Feature ArticlesFeature Articles

    The SaMD regulatory landscape in the US and Europe

    The advent of artificial intelligence (AI) in the healthcare industry has resulted in a proliferation of novel health technologies with intuitive features. However, the regulatory landscape for such innovative products has yet to be fully understood. The US Food and Drug Administration (FDA) published a discussion paper on AI- and machine learning (ML)‒based software as a medical device (SaMD) in April 2019, which led to the release of an action plan that incorporated stak...