Name: CTA 2124 – Characteristics and Requirements for Integrated Continuous Glucose Monitoring (iCGM) Solutions for Consumer Use Cases
Brand: Consumer Technology Association
SKU: CTA 2124
Price: 85.00 USD
Availability: InStock

CTA 2124

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Characteristics and Requirements for Integrated Continuous Glucose Monitoring (iCGM) Solutions for Consumer Use Cases

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CTA 2124

This standard provides guidelines and identifies design considerations for consumer general wellness software products that use data from Integrated Continuous Glucose Monitors (iCGMs), generally focused on overarching health and wellness and the electronic display of medical device data, which may include certain remote or secondary displays that solely display iCGM data and do not enable immediate awareness for potential clinical intervention. The use of iCGM data in mobile applications (mobile apps) for general wellness purposes may be helpful in monitoring athletic performance, enabling lifestyle changes, promoting healthy living, among other use cases. The use of iCGM data in mobile apps for electronic display purposes may be helpful in facilitating the remote or secondary display of information from an iCGM. If developing a product that uses iCGM data for a medical purpose, your product may be subject to US Food and Drug Administration (FDA) regulatory oversight and is outside the scope of this standard. Refer to US FDA guidance documents with digital health content for considerations on how to design, develop, and test products intended for a medical purpose. Medical devices are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21 Code of Federal Regulations (21 CFR) based on the risk of the device. FDA considers a product to be a medical device if it meets the definition of a device per Section 201(h) of the FD&C Act. This includes software and hardware products intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. [1]

CTA 2124

Characteristics and Requirements for Integrated Continuous Glucose Monitoring (iCGM) Solutions for Consumer Use Cases

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