FDA Aims To Reduce 510(k) Review Times With New Submission Acceptance Process
This article was originally published in The Gray Sheet
Executive Summary
Draft guidance outlines criteria that 510(k) submissions must meet before the agency begins its substantive review.
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Washington Roundup, October 2012
The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover FDA’s enforcement action against CardioMEMS for alleged clinical trial violations, medical device user fee agreement implementation, and AdvaMed’s priority list for the fiscal-cliff bill.