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