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App Developer's Vision of Regulation Imposed by FDA

There are around 40,000 medical apps available at various app stores around the world. The apps developing industry is still an infant and experts believe that the best is yet to come. This significant rise in

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There are around 40,000 medical apps available at various app stores around the world. The apps developing industry is still an infant and experts believe that the best is yet to come. This significant rise in the number of health apps has left the FDA (Food and Drug Administration) raising its eyebrows over this issue. There is no doubt that smart phones and apps offer opportunities for better health monitoring and patient's wellness. These devices and technologies have abolished the hassles of visiting a doctor every single time with a same ailment. Few of these apps have replaced devices like glucometer and high quality microscopes in our hospitals.


Until now, apps developing industry is operating in an unregulated manner with no one present to monitor effectiveness and accuracy of mobile health apps. It was only last year that FDA started to lay a law regarding this. It initiated with drafting the guidelines stating that app developers engaged in developing health related apps will need to apply to FDA and seek its approval before launching their apps. Another very crucial instruction was that all the smart devices used for health care purposes would require proving their safety aspect and effectiveness prior to use for any medical intention. Both medical world and app developers were excited about the increasing importance of apps as an assistive tool for enhancing the quality of the medical services. Now they have received a jolt of a lifetime by these two guidelines. Time and money taken by FDA in reviewing and approving a device are the main concern for the developers. There is another fraternity that believes that rules laid by the FDA are not sufficient and the government should set up a new regulatory to control mobile app development, assessment and approval process. They suggest that app developers with products such as healthy eating apps should be freed from getting FDA approval, as they will be developing more or less, general wellness and fitness apps.


According to General Accountability Office, time taken by the FDA to approve a medical device that is similar to an existing product is around 6 months. For a brand new device, it takes around 20 months for assessment and approval. App developers feel that the procedure is too slow and healthcare apps are increasing drastically. Therefore, there is no compatibility in between and these two lifecycles are very different from each other. Similarly, if we examine a report released by Stanford University, we will notice that the cost of finding an app or a device approved by FDA is very high. It ranges anywhere between USD 24 million and USD 75 million.


Despite all this, many are supporting FDA and saying that although this process will delay the development but it is important for safeguarding consumers. Mr. Alain Labrique from John Hopkins University claims that most apps are much hyped by their developers. He says that although smart devices and apps allow us to amplify quality of the services but it is very important to support the claims made by developers by data assessment and testing on stiff parameters. He further says that a developer's consideration towards commercial and monetary gain could lead him to overstate about what his apps are actually capable of accomplishing.


Amidst all this, it is expected that the FDA will release its final verdict of the rules for developing health related apps later in this year. Apps development companies have geared up to tackle it. Most of them have even started the initial process of apps development with the hope given by FDA by approving a handful of apps already.


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The author is associated with one of the top enterprise mobile app development companies, mobile app development Noida and enterprise mobility consultants

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