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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?
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.
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 | 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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