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Washington Roundup, September 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 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.

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Policy Makers Ponder Sending Device Data To Electronic Health Records

In the not-too-distant future, health care providers should be able to accept patient data from blood pressure cuffs, glucose meters and mobile health apps for integration into electronic health records.

FDA Releases Proposed Rule On UDI System, Ushering in ‘Modern Post-Market Surveillance System’

A proposed FDA regulation for a Unique Device Identification System is critical to the future of post-market safety surveillance, the agency says. The UDI system aims to reduce medical errors, and provide an array of other benefits for supply chain management. Makers of high-risk class III products will have one year to place UDI codes on devices. The UDI mandate will extend to moderate-risk class II devices two years later and to some low-risk class I devices two years after that.

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

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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