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TOPIC: FDA proposes expedited access for medical devices

FDA proposes expedited access for medical devices 22 Apr 2014 15:23 #1580

  • joeycav11
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FDA proposes expedited access for medical devices 22 Apr 2014 15:48 #1582

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Highly interesting.

From the responsiveness and accessibility of the FDA- as Cytori has been reporting in CCs in the past 2 years about- one would almost think the FDA did a "dry-run" on these procedures with Cytori.

I do not think it changes a whole lot- it just happens to be good when you are an IDE i.e. a device Company, working with high risk devices on the PMA regulatory route and not be an IND so to speak. :cool:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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