aime_nathan_BUS311_WK8Paper - The FDA Proposed Regulations...

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The FDA Proposed Regulations for Medical Apps With the latest craze of mobile phone applications, there is an app for almost anything you can think of. The latest proposed regulation from the Food and Drug Administration has its eye on regulating some of those apps that provide medical or health guidance to you. The FDA claims that they do not want to discourage the new apps from being developed, oversight is what they desire. Particularly on the apps that pose the largest amount of risk to the patients who use them in the event they do not work as they are intended. There is a new trend occurring in mobile app development, in which the regulations are being targeted towards, in which iPhone and iPad applications are being used to create integrated, portable medical devices to take the place of the computer terminal and paper chart in every hospital room of today. Hospitals around Canada and the United States of America have been testing the use of the iPad and iPhone. The biggest thing the proposal is trying to do is to give jurisdiction to the FDA over devices that meet its current definition and criteria of a medical device. At this current time, the FDA lacks clear control over iPhone or iPad apps that could be used as medical devices, since the iPhone and iPad are not necessarily medical devices on their own. Currently, Section 201(h) of the FD&C Act defines a medical device as: an apparatus,
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aime_nathan_BUS311_WK8Paper - The FDA Proposed Regulations...

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