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US FDA to regulate only medical apps that could be risky if malfunctioning |
September 24, 2013
The U.S. Food and Drug Administration intends to regulate only mobile apps that are medical devices and could pose a risk to a patient's safety if they do not function as intended.Some of the risks could be unique to the choice of the mobile platform. The interpretation of radiological images on a mobile device could, for example, be adversely affected by the smaller screen size, lower contrast ratio and uncontrolled ambient light of the mobile platform, the agency said in its recommendations released Monday. The FDA said it intends to take the "risks into account in assessing the appropriate regulatory oversight for these products."The nonbinding recommendations to developers of mobile medical apps only reflects the FDA's current thinking on the topic, the agency said. The guidance document is being issued to clarify the small group of mobile apps which the FDA aims to scrutinize, it added.The recommendations would leave out of FDA scrutiny a majority of mobile apps that could be classified as medical devices but pose a minimal risk to consumers, the agency said.To read this article in full or to leave a comment, please click here
Link: http://www.pcworld.com/article/2049289/us-fda-to-regulate-only-medical-apps-that-could-be-risky-if-malfunctioning.html#tk.rss_all
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