Washington Roundup, August 2012
Executive Summary
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.
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The first month of the diagnostics office’s “triage” pilot program has led to quicker reviews for some 510(k)s, an agency official reports. To qualify for the program's quick-review pathway, a submission must be of high quality and free of certain time-consuming complexities.
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