Category Archives: Medical Apps

Final Guidance on Medical Apps

In July 2011, FDA issued a draft guidance on Medical Apps that set out the agency’s approach to regulate apps – even as thousands of such apps were being developed and downloaded by users.  Just over two years later in … Continue reading

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FDA “It Has Come to Our Attention” Letter on Medical App

There are Warning Letters, Untitled Letters, otherwise known as Notice of Violation Letters, and now there is the “It Has Come to Our Attention Letter”.  I have to admit, I had not heard of this particular kind of letter before, … Continue reading

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Expanding World of Medical Apps – Quantity and Quality

This weekend the Washington Post carried an article that, among other things, focused on the explosion of apps available in healthcare. Entitled “Health-care Apps of Smartphones Pit FDA Against Tech Industry” the primary thrust of the article was as the … Continue reading

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