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Ann: FDA Strategy and Regulatory Update, page-47

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tiikei

86 Posts.

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07/08/20

14:02

Post #: 46379183
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Originally posted by Thuynh: ↑

If you Read it carefully there is nothing bad here
FDA 510(k) Application for MEBsleep
In line with the typical 510(k) evaluation process, Medibio recently received queries from the FDA prior
to its submission being officially accepted for review. The queries are largely around clarification of
intended use and substantial equivalence to the chosen predicate device. Substantial equivalence
requires that MEBsleep has the same intended use as the chosen predicate device and has the same
technological characteristics, or has different technological characteristics and the information submitted
demonstrates that the device is as safe and effective as the chosen predicate device.
The Company has responded to the FDA’s queries and awaits further correspondence. Upon FDA’s
satisfaction of Medibio’s response, MEBsleep will be officially accepted for review. Medibio remains
positive of clearance and is actively seeking commercial collaborations and opportunities for MEBsleep in
anticipation of FDA clearance.

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Shouldn't everything that you haven't highlighted have been disclosed in an update 'recently'? My sentiment hasn't changed based on the part you did highlight though. Just wondering is all.

MEB Price at posting: 1.1¢ Sentiment: Hold Disclosure: Held
1 Upvote

0 Great analysis

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