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Risk And Benefit, Quantified: CDRH Expands Use Of New Statistical Framework

This article was originally published in The Gray Sheet

Executive Summary

Decision analysis tools will be put into practice as part of the device center’s priority “innovation pathway” for breakthrough devices and in a pilot program focused on obesity devices. The techniques may allow for shorter development and review cycles, among other benefits, CDRH says.

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Washington Roundup, September 2012

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover FDA’s recently unveiled plan to strengthen device post-market surveillance, a report from AHRQ on the impact of bundled payments on health care spending and quality, and new rules released by CMS that encourage providers to make diagnostic images accessible through electronic health records.

FDA Unveils Plan To Strengthen Device Post-Market Surveillance

Combining new techniques with improvements to current tools, the strategy aims for "near real-time" post-market surveillance.

CDRH Applies “Grand Rounds” Approach To Risk-Benefit Balancing

Device center staffers met to discuss several pending applications and the factors that should weigh heaviest in their review.

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