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U.S. Food and Drug Administration (FDA) (2023) Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-
fee-and-modernization-act-2002-validation-data-premarket-notification

has been cited by the following article:

• TITLE: Smartphone Oximeter SpO2 Integrated Measurement

  AUTHORS: Yahweh Van Ram Sri

  KEYWORDS: Biosensors, Smartphone, Hypoxia, Pulse Oximeter, Photoplethysmography

  JOURNAL NAME: Open Access Library Journal, Vol.11 No.7, July 25, 2024

  ABSTRACT: Smartphone-based Oximetry device as early healthcare detection is a technological frontier. Smartphone oximetry devices offer a convenient method for remote SpO2 monitoring and early detection of critical health issues, especially during pandemics when vital indicators are necessary. Rising healthcare demands, and the COVID-19 pandemic are recent causes necessitating the prevalence for accessible early detection tools. This research investigates smartphone oximetry device as a convenient SpO2 monitoring, crucial for identifying hypoxia, a silent risk factor in medical conditions. The selection criteria for Samsung Note 10 smartphone following the research aims to perform 1) Literature Review to analyse articles showcasing smartphone oximetry functions and importance of Photoplethysmography Sensors for accurate SpO2 measurement. 2) The smartphone (Samsung Note 10) was selected for compatibility with FDA/ISO medical device standards. 3) To develop a User Requirements Document (URD) for the chosen smartphone, outlining user needs and functionalities for optimal performance. Smartphone-derived SpO2 measurements met full FDA/ISO accuracy requirements following RMSD 2.6% vs Table 1. This aligns with the critical role of pulse oximeters in managing COVID-19 patients and detecting silent hypoxia.