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FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health
 

FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health

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Given pending mobile medical apps guidance from the FDA, Rock Health has developed a guide for digital health entrepreneurs trying to navigate the FDA process. The report covers the current scope of ...

Given pending mobile medical apps guidance from the FDA, Rock Health has developed a guide for digital health entrepreneurs trying to navigate the FDA process. The report covers the current scope of regulatory oversight, device classification and premarket requirements for digital health companies creating regulated products. Digital health entrepreneurs that have successfully navigated the process offer pointers and best practices to startups.

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  • Very useful. Lot of grey area in terms of applicability but looks like only was is to go through the process.
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  • Nice deck, but you really should turn on 'download'. Making people save 26 images (which is still available, regardless) is just silly.
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  • very well done
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  • Impressive information
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  • Excellent presentation! Any sense of how much should be budgeted for investment in this type of process? Having specific regulatory expertise on staff for the length of time needed could add up. Thanks!
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    FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health Presentation Transcript