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FDA Reveals Final Mobile Health App Guidelines
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David F. Carr
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David F. Carr,
User Rank: Author
9/23/2013 | 11:30:50 PM
re: FDA Reveals Final Mobile Health App Guidelines
Are these binding guidelines? Do we have any idea how many apps currently on the market might be in violation of them?
Thomas Claburn
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Thomas Claburn,
User Rank: Author
9/24/2013 | 4:06:25 AM
re: FDA Reveals Final Mobile Health App Guidelines
I'll be interested to see what it costs to develop a regulated app as opposed to a non-regulated one.
dbtinc
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dbtinc,
User Rank: Apprentice
9/24/2013 | 12:59:43 PM
re: FDA Reveals Final Mobile Health App Guidelines
deviation from guidelines in the absence of information explaining why non-compliance to a guideline usually will result in non-approval of a new or improved medical device or regulatory action against a cleared device.
dbtinc
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dbtinc,
User Rank: Apprentice
9/24/2013 | 1:00:32 PM
re: FDA Reveals Final Mobile Health App Guidelines
It will of course be more expensive but non-compliance to a guideline may result in FDA not approving (clearing) the device. It also sets up a greater risk of product liability as well.
ChrisMurphy
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ChrisMurphy,
User Rank: Author
9/24/2013 | 9:58:07 PM
re: FDA Reveals Final Mobile Health App Guidelines
Also key to watch if it creates barriers to startups -- will innovators avoid regulated areas, or be drawn to them as more defensible?


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