Thursday, July 5, 2012

How Congress almost delayed the FDA’s mobile medical app guidance

I can't wait to see what's in the final guidance, when it's finally published.

How Congress almost delayed the FDA’s mobile medical app guidance | mobihealthnews:

"Much has been written in the past few weeks about Congress’ efforts to put its mark on the FDA’s regulation of mobile medical apps. I was curious how this issue of 510(k) clearance for mobile apps became a topic of interest for Congress. The FDA published its draft guidance a year ago now. After hundreds of companies weighed in with their thoughts on the document, the industry widely expects a final guidance document any week now. Why did the Senate take an interest in medical app regulation this past spring? Who asked them to? And, what exactly did their conversation sound like?"

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