Journal: Drug Invention Today

Article Id: JPRS-P'Col-00005312
Title: Software as a medical device: Need of the hour
Category: Pharmacology
Section: Review Article
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    The rapid increase in smartphone use in the 21st century led to the introduction of many stand-alone health and medical devices. “Software intended to be used for one or more medical purposes without being part of a hardware medical device is referred as software as a medical device.” The design and regulatory science of software as a medical device (SaMD) depend on the early stages of software development that helps to assign them to a different category of medical devices. Globally, there are tremendous technological innovations available that offered the opportunity to pursue a more efficient diagnosis and therapeutic solution compared to conventional approaches. The major benefits include tracking and altering the occurrence of a disease and improved health outcomes through rapid feedback, resulting in faster innovation. Apart from the advantages, there are some technological challenges faced by SaMD such as maintaining the confidentiality, availability, and integrity of patient data. The main objective is to provide the regulatory outline on the SaMD’s for safe and effective use by patients. The regulatory framework of both USFDA and EMA for software has been well structured when compared to other regulatory agencies. However, more focus needs to be paid to pre-market criteria and the road to regulatory approval. The present study highlights the regulatory requirements for registering the SaMD in USA and European countries.

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    Author(s) Name:

    S. Narmada, V. Balamuralidhara*, M. P. Venkatesh, M. P. Gowrav

    Affiliation(s) Name:

    Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, India

    *Corresponding author: V. Balamuralidhara, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru - 570 015, Karnataka, India.

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    Author:

    S. Narmada, V. Balamuralidhara*, M. P. Venkatesh, M. P. Gowrav

    Title:Software as a medical device: Need of the hour
    Journal:Drug Invention Today
    Vol(issue):13 (February )
    Year:2020
    Page No: (145-155)
  • Experimental Methods Keywords

    Methodology:Clinical validation, Digital health, Medical devices, Software as a medical device, Stand-alone software
    Research Materials:Active therapeutic instruments

Keywords

Active therapeutic instruments Clinical validation Digital health Medical devices Software as a medical device Stand-alone software

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