FDAnews Device Daily Bulletin

CARDIAC MANAGEMENT DEVICES PROPOSAL RELEASED BY ADVAMED

March 23, 2006
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AdvaMed has released a proposal for Pulse Generator Product Performance Reports, designed to improve communications between the manufacturers of cardiac rhythm management devices and patients, providers, and the public.

The purpose of the new proposal is to help ensure that key stakeholders have a better understanding of the performance of the lifesaving medical technologies.

"AdvaMed and the medical technology industry are committed to ensuring physicians and their patients have the best information available to make important health care decisions," said Stephen Ubl, AdvaMed president and CEO.

This new reporting format, which is based on an ISO standard, establishes definitions and requirements for companies to follow when issuing device performance reports. AdvaMed conferred with the FDA and the Heart Rhythm Society during the document's development. While the document is still in draft form, AdvaMed member companies are now issuing their first reports based on the new report format to evaluate it and receive stakeholder feedback.

To download AdvaMed's "Proposal for Requirements for Uniform Reporting of Clinical Performance of Pulse Generators," go to http://www.advamed.org/publicdocs/PPR_proposal_030306.pdf (http://www.advamed.org/publicdocs/PPR_proposal_030306.pdf)