The Heart Rhythm 2011 Health Policy Town Hall is divided into two distinct sessions. In the first session, the FDA will discuss its perspectives on several topics related to EPs such as AF Ablation and pre-market approval process. The second session will feature leading physicians engaging in a lively discussion regarding the value of registries as a quality improvement tool.

Session Chair: Richard I. Fogel, MD, Heart Rhythm Society Health Policy Chair; The Care Group in Indianapolis

Session One: Regulation of Devices throughout the Total Product Life Cycle
This Town Hall session focuses on the FDA's perspectives on several salient topics, including pre-market approval, AF ablation; and the MRI and implantable pulse generators.

FDA Update 2011

• Mitchell J. Shein, MS, FDA in Silver Spring, Md.

EMC Issues including Radio Frequency Identification

• Soma S. Kalb, PhD, FDA in Silver Spring, Md.

Expanding and Limiting Indications for CRT

• Kimberly A. Selzman, MD, FDA in Silver Spring, Md.

Diagnostics in Implantable Devices, Data Requirements, Tool Claims

• Brian M. Lewis, MD, FDA in Silver Spring, Md.

Q&A Session

Session Two: Why Collect Longitudinal Data?
The second Town Hall session addresses the value of registries as a quality improvement tool. Experts will address registry use in Europe and discuss the benefits and obstacles to registries in the United States.

Quality Improvement, Payment: Pay for Performance, Public Accountability, Research

• Kathleen Blake, MD, New Mexico Heart Institute in Albuquerque, N.M.

Advantages of Registries

• Stephen C. Hammill, MD, Mayo Clinic in Rochester, Minn.

Disadvantages of Registries

• Eric N. Prystowsky, MD, The Care Group in Indianapolis

The Danish Pacemaker and ICD Registry

• Jens B. Johansen, MD, PhD, Aarhus University Hospital, Cardiology in Aarhus, Denmark

Q&A Session