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Does Your Mobile App Need FDA Approval? [Infographic]

FDA mobile app guidelines

When is a smartphone no longer just a smartphone but instead considered a regulated medical device by the Food and Drug Administration (FDA)? Mobile medical apps are rapidly introducing  new and innovative ways to improve healthcare and patient care. The FDA consistently regulates these apps to ensure their  safety and effectiveness. Let us explore the apps regulated by the FDA and any possible discretions through the infographic provided.

FDA mobile app guidelines

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Mobile applications are being adopted as quickly as they are developed. Since these healthcare applications help people manage their health and fitness, they are becoming  fashionably popular. Recent estimates show that by the end of 2015, 500 million users worldwide will be using a health care application and 50 percent of over 3.4 billion smartphone users will have downloaded a mobile health app by the year 2018. The Food and Drug Administration issues guidelines from time to time to highlight the apps that are regulated as well as those that fall under their discretion. Development and use of mobile medical apps that help improve health care and provide consumers with valuable health related information has always been encouraged by the FDA, provided these apps don’t pose a threat to its users if they fail to work as intended.

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1 Comment

  1. […] When is a smartphone no longer a smartphone and instead considered a regulated medical device by FDA? Does your medical app need FDA approval…  […]

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