FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | FDA Centennial

FDA Statement

FDA Statement on Recommendations to FDA From the Heart Rhythm Society Task Force on Device Performance Policies and Guidelines

The U.S. Food and Drug Administration (FDA) values the relationship it has with the Heart Rhythm Society (HRS) and regards it as a model for how the agency can work collaboratively with provider groups to improve the environment for safe and effective use of medical products. In particular, over the past year, FDA and HRS have worked together to improve the conditions for safe and effective use of cardiac rhythm management devices. That has resulted in a new set of recommendations from HRS regarding how the broader healthcare community -- including FDA -- can take additional steps to make more effective use of these products.

Cardiac rhythm management devices are important devices that have saved countless lives. These devices include pacemakers and implantable cardiac defibrillators (ICD). The recent article from HRS identified specific recommendations that multiple healthcare stakeholders, including FDA, can take concerning ICD and pacemaker performance issues and advisories to patients and doctors. Recommendations to FDA include:

• use simpler language to communicate important information about device malfunctions and eliminate the term "recall" in public communications;
• enhance the existing postmarket surveillance databases to more readily identify devices that may pose a danger to patients; and
• establish a postmarket surveillance advisory panel of independent experts to assist FDA with its postmarket activities.

FDA has already implemented one of HRS' key recommendations by expanding the charge of our standing cardiac advisory device panel beyond premarket issues to address device postmarket safety and effectiveness. Members of this postmarket panel have already provided feedback to FDA on internal evaluations associated with cardiac rhythm device malfunctions.

Additionally, we are in the process of implementing other key HRS recommendations, some of which can yield results relatively soon, with others being implemented and showing results over a longer term. For example, we are looking at ways to enhance our postmarket surveillance systems and have taken steps to more clearly explain FDA's current terminology to the public and physicians. Over the next year the agency will continue to develop these initiatives in an interactive fashion with HRS and other key stakeholders.

FDA appreciates this latest input and encourages HRS, as well as other societies, to continue to provide recommendations to the agency. Through these collaborations, FDA can enhance its relationship with key stakeholders and use their expert advice to better inform its thinking and policy making.

####

RSS Feed for FDA News Releases [what's this?]

Get free weekly updates about FDA press releases, recalls, speeches, testimony and more.

FDA Newsroom
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Website Management Staff