Heart Rhythm Society continues to influence FDA risk advisory notices

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Heart Rhythm Society Continues to Influence FDA Risk Advisory Notices

The Heart Rhythm Society is fully committed to improving device performance communication and welcomes the opportunity to work closely with the FDA Risk Advisory Committee.

The Heart Rhythm Society presented a statement from its recommendations in the 2006 Device Performance Policies and Guidelines document during testimony in front of a newly established 15-member Food and Drug Administration (FDA) Risk Communication Advisory Committee on February 29, 2008.

View the Heart Rhythm Society's written testimony (PDF, 128K).

On February 28, 2008, the committee met for the first time, for presentations and discussion of the relation of FDA's risk communication programs and FDA's responsibilities. On February 29, 2008, the meeting continued with presentations and discussion of FDA's proposed template for press releases announcing product recalls with a view to incorporating best practices of risk communication.

The Risk Advisory Committee was established to:

help FDA better understand the communication needs and priorities of the general public
advise FDA on the development of strategic plans to communicate product risks and benefits; and
make recommendations to FDA on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information to vulnerable audiences.

The Heart Rhythm Society will continue to work with the new FDA Committee on the development of its risk advisory template; we believe the advisory notices need to contain comprehensible, accurate, science-based information for all.