ODE management initiatives
This article was originally published in The Gray Sheet
Executive Summary
Blue-book memoranda on Office of Device Evaluation's review initiatives -- device triage, expedited review, and refusal to accept/file premarket and investigational device submissions -- are released the week of May 23. The memos are essentially unchanged from policy documents on the initiative unveiled in July 1993 ("The Gray Sheet" July 5, p. 2)
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