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FDA’s Role in Regulating Mobile Devices and Apps
Sep 18, 2024
The Food and Drug Administration (FDA, 2024) does not regulate smartphones, tablets, or mobile app stores directly, as these devices and platforms serve various non-medical purposes and are not inherently medical in nature. However, the FDA does regulate mobile medical applications that are intended to diagnose, treat, or prevent medical conditions. For example, an application that analyzes heart rhythms or monitors blood glucose levels would be regulated by the FDA, but the hardware (like smartphones) and the app stores that distribute these apps are not.
Considering the above, the FDA’s regulation of mobile medical applications benefits the public significantly by ensuring the safety, effectiveness, and reliability of these critical health-related technologies. One clear example is the Apple Watch ECG feature, which can monitor heart rhythms and detect atrial fibrillation (FDA, 2024). FDA regulation ensures that the data provided by this app meets specific medical standards, giving users confidence that the information they receive is accurate and actionable. This regulatory oversight minimizes the risk of false positives or negatives, helping users avoid unnecessary stress or delayed medical attention (Gordon et al., 2020).
Another example of the FDA’s regulatory impact is its oversight of continuous glucose monitoring (CGM) apps, such as those used by diabetic patients to track glucose levels. These apps are critical for managing diabetes effectively, and FDA involvement guarantees that the data collected and displayed is accurate and reliable(Kernebeck et al., 2020). Without this regulation, there would be a higher risk of inaccurate glucose readings, which could lead to improper insulin dosing, resulting in serious health consequences such as diabetic ketoacidosis or severe hypoglycemia.
On the other hand, the FDA does not regulate the hardware (smartphones and tablets) or mobile app stores, and there is no strong reason to extend regulation to these areas. For example, regulating the Google Play Store or Apple’s App Store would create unnecessary complications, as these platforms host millions of apps, most of which are not related to healthcare (Lievevrouw et al., 2022). Requiring FDA approval for all apps would not improve public safety but would slow down the development and release of useful applications, including those that have no medical function.
Similarly, regulating smartphones or tablets as medical devices would not make sense, as these devices are primarily designed for communication, entertainment, and general productivity. Applying FDA oversight to these devices would likely stifle innovation and add unnecessary costs to consumers without improving public health outcomes (Ventola, 2024). It is more efficient for the FDA to focus on regulating the specific software that turns these devices into medical tools, ensuring that these apps meet strict standards of safety and efficacy.
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