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In July 2011, FDA issued a draft guidance on Medical Apps that set out the agency’s approach to regulate apps – even as thousands of such apps were being developed and downloaded by users.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