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Re: slaw5904 post# 37549

Thursday, 05/01/2014 10:27:21 AM

Thursday, May 01, 2014 10:27:21 AM

Post# of 335045
May 1 slaw
I believe that being in the month of partial reckoning, i.e. FDA closes its comments to creating a new class of devices window puts us that much closer psychologically. I am interested in knowing what steps and timing the FDA suggests from 'May comment deadline' going forward. Call for 510K's? A 'hard' assessment period?

What will one solid PR or just 1 snippet of solid meaty news in the device community do?

I would find it astounding if a number of large players in pharma and devices are not watching this. I posted many, many months ago if I were the CEO at J&J, ex-director of their devices division, I would be looking at it. At least verrrrry aware. Thoughts?