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Shuren On The Hill: Industry Should Take More Blame For Review Delays

This article was originally published in The Gray Sheet

Executive Summary

CDRH Director Jeffrey Shuren called out industry during a Feb. 17 House subcommittee hearing for playing a significant role in causing delays in pre-market device reviews.

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Washington Roundup, August 2012

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we report on recent FDA proposals to streamline the 510(k) and PMA submission processes and the ongoing investigation into FDA surveillance of CDRH employee whistleblowers.

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Draft guidance outlines criteria that 510(k) submissions must meet before the agency begins its substantive review.

FDA Focuses On Weeding Out Deficient PMAs

A draft guidance document designates “acceptance” criteria that when not met by a PMA will allow a reviewer to send the submission back to the sponsor more quickly.

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