Society Testifies at FDA Risk Communication Meeting

	Coding & Reimbursement
	ICD Registry
	Device & Drug Safety
	Research & NIH Funding
	Clinical Guidelines
	Legislation/ Take Action

Home > Health Policy > Device & Drug Safety > Device Performance

Society Testifies at FDA Risk Communication Meeting

While testifying at the FDA Risk Communication Advisory Panel meeting, William Maisel, MD, MPH, presented the recommendations from the Society's 2006 Device Performance Policies and Guidelines document and urged the FDA to reconsider the use of the word "recall."

The Heart Rhythm Society testified at the FDA Risk Communication Advisory Committee on Thursday, August 14, 2008. This is the second time that the Society presented its recommendations to the Risk Communication Advisory Committee (view past testimony) . The Committee is a public advisory panel of the Food and Drug Administration (FDA). It was convened approximately one year ago to provide advice and recommendations to the agency on effective risk communication.

William H. Maisel, MD, MPH represented the Heart Rhythm Society and reminded the FDA and members of the advisory panel that cardiac implantable electronic devices are not the same as spinach or pet food and should be treated differently.

Maisel urged the FDA and panel members to rethink how their communication is interpreted; that one word can mean many things and cause much unnecessary panic; especially when using the word “recall” for an implantable device. View Dr. Maisel's presentation (PDF, 544K)

For more information on the public hearing on risk communication, please visit the Risk Advisory Committee's website.