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Alias Born 01/13/2009

Re: tryn2makamil post# 2556

Tuesday, 12/15/2009 9:29:22 AM

Tuesday, December 15, 2009 9:29:22 AM

Post# of 18453
TYRN2, were you ever able to get in touch with anyone at HDC to confirm whether or not the company has received the 510K submission draft from Abbott? According to your Nov.,2009 post "Abbott will provide a draft of the submission to HDC for its comment at least thirty (30) days before the actual filing with the FDA." This 510K filing will be big news, however that is not due to happen until HDC is first given 30 days to read over the draft. Does anyone know if HDC has received this draft yet? The way I read it, that will be the signal that starts the clock on the 510K submission news
we are eagerly waiting for.
"2.1.2 Initially, Abbott will be solely responsible for the preparation and submission of the 510(k) or PMA application to the FDA. Abbott will provide a draft of the submission to HDC for its comment at least thirty (30) days before the actual filing with the FDA. However, the parties may agree in writing to a change in the allocation of responsibility. In this event, any such writing will modify the FDA Submission Plan to establish each party’s responsibilities and whether any additional time or funding is required."