This paper is in the following e-collection/theme issue:

Digital Health Reviews (1544) Clinical Informatics (1172) Theoretical Frameworks and Concepts (297) Quality Improvement (276) Adoption and Change Management of eHealth Systems (807)

Published on in Vol 25 (2023)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/47505, first published .
Innovation Process and Industrial System of US Food and Drug Administration–Approved Software as a Medical Device: Review and Content Analysis

Innovation Process and Industrial System of US Food and Drug Administration–Approved Software as a Medical Device: Review and Content Analysis

Innovation Process and Industrial System of US Food and Drug Administration–Approved Software as a Medical Device: Review and Content Analysis

Authors of this article:

Jiakan Yu1 Author Orcid Image ;   Jiajie Zhang2 Author Orcid Image ;   Shintaro Sengoku1, 3 Author Orcid Image
Article Authors Cited by (6) Tweetations (7) Metrics

Journals

  1. Weimar S, Martjan R, Terzidis O. Conceptualizing the landscape of digital health entrepreneurship: a systematic review and research agenda. Management Review Quarterly 2025;75(2):1619 View
  2. Yew S, Trivedi D, Adanan N, Chew B. Facilitators and Barriers to the Implementation of Digital Health Technologies in Hospital Settings in Lower- and Middle-Income Countries Since the Onset of the COVID-19 Pandemic: Scoping Review. Journal of Medical Internet Research 2025;27:e63482 View
  3. Francesconi M, Cangi M, Tamarri S, Conditi N, Menicucci C, Ravizza A, Cattaneo L, Bianchini E. Navigating regulatory challenges across the life cycle of a SaMD. Journal of Biomedical Informatics 2025;167:104856 View
  4. Singh V, Cheng S, Kwan A, Ebinger J. United States Food and Drug Administration Regulation of Clinical Software in the Era of Artificial Intelligence and Machine Learning. Mayo Clinic Proceedings: Digital Health 2025:100231 View
  5. Martjan R, Weimar S, Terzidis O. A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study. Journal of Medical Internet Research 2025;27:e67328 View

Books/Policy Documents

  1. Klüglich M. Global Bioethics - Current Challenges, New Developments, and Future Directions [Working Title]. View