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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.

The US Food and Drug Administration (FDA) put its long-simmering concerns about CardioMEMS Inc.’s CHAMPION clinical trial into legal form with a warning letter recently, citing the firm for numerous regulatory violations.

The June 5 warning letter to CardioMEMS, which was made public on FDA's web site September 25, details alleged sponsor...

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