Saturday, November 07, 2015 9:53:55 AM
Communication long before the filing of the 510(k)
The "invite" to file 510(k) pre-Final Order, I have read that.
ActiPatch does fit into new Class II - check!
Why reveal 510(k) status, NOT? To protect a business position. Called smart!
Anything wrong with being first?
Does anyone know if any other manufacturer filed a 510(k)? NO
Are shareholders and public entitled to know business tactics? Never. Called stupid.
Is the 90 days just an estimate of hope? Of course.
Is the 90 days just including "FDA Days? Yes.
Does elapsed time include FDA Days and FDA Hold Days? Of course.
Can a 510(k) assessment clear a device in a week or two? Sure.
Does that happen often? What do you think?
Is the main reason for hiring experts to do 510(k)'s getting it right and avoiding AI's Yes
Are AI's pretty common? Hundreds, every day. Because more data or clarifications are required.
Load up folks.
My prediction? Soon. . . . .
Definition of soon? Merry Christmas!
Why wait? Drug-free, side-effect free, fits into new Class II
Truth and common sense.
FDA got it right, we're safe, tens of millions of Americans with chronic pain will benefit.
Just common sense.
Go BIEL, the little Maryland company that could, I mean did. . . . .
Great journey, great story, so far, more to come. . . . .
Yamayama
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