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Washington Roundup, October 2012

Executive Summary

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.

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User Fee Limbo: FDA Will Not Have Access To Extra Industry Funds At FY 2013 Start

The new fiscal year starts Oct. 1, but FDA will not be able to spend the full amount of fiscal year 2013 industry user fees as a result of an emergency spending bill, and Congress is not expected to fix the issue until after the election in November at the earliest.

Industry Praises PMA-Acceptance Draft Guidance, But Offers A Few Suggestions

Companies are generally happy with FDA’s July 31 draft guidance describing a 15-day "acceptance review" that FDA staff will perform to quickly check that a PMA submission meets minimum requirements.

FDA Aims To Reduce 510(k) Review Times With New Submission Acceptance Process

Draft guidance outlines criteria that 510(k) submissions must meet before the agency begins its substantive review.

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