Friend, the press release clearly supports my understanding of Heather's role, which is based on my experience with the FDA. The report states: "A major player in CDRH’s 510(k) process is stepping down just as the agency begins to revamp the device clearance program." She is being identified as a major player in terms of the revamp of the entire program. That's the level at which she operates... developing and maintaining the "program," not down at the individual application level. The "review team" is made up of the Reviewer, his immediate supervisor (who is not Heather), and Jeff Shuren. Heather is not involved in the review and decision of the DViS application at all.
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