As noted above, Heart Rhythm Society recommends that Congress recognize the importance of post-market surveillance, analysis, and reporting of ICDs and pacemakers in ensuring patient safety. However, the Food & Drug Administration (FDA) does not currently have the resources to make the necessary enhancements to the surveillance systems.

Funding for the FDA has not kept pace with inflation, while the agency’s responsibilities have expanded. In order to ensure that Congress makes the required commitment to ensure timely access to safe medical devices and restore public confidence in the agency, the Society  has joined forces with more than 180 members to form the Alliance for a Stronger FDA, which is comprised of patient groups, nonprofit organizations, consumer advocates, public health organizations and companies from the food, pharmaceutical and medical devices sector, as well as three former Secretaries of the U.S. Department of Health and Human Services and six former FDA commissioners.

2008

The Society Continues Congressional Visits to Ensure Resources for Device Safety (02/2008) — As part of the Alliance for a Stronger FDA, the Heart Rhythm Society met with the offices of Representative Jo Ann Emerson (R-MO), member of the Appropriations Committee and Senator Sam Brownback (R-KS), ranking member of the Subcommittee on Financial Services and General Government to talk about the funding of FDA. Learn more »