On Health Policy Archives

Comments to the CDC on Hepatitis C Virus Screening

June 6, 2012. NRC supports CDC’s expansion of guidelines for Hepatitis C screening for baby boomer adults.

NCHR Testimony in Support of the Ensuring Safe Medical Devices for Patients Act

March 15, 2012. Paul Brown, NRC’s Government Relations Manager, released a statement supporting Senator Merkley’s bill, “Ensuring Safe Medical Devices for Patient Act” that requires the Food and Drug Administration (FDA) to establish a Unique Device Identifier (UDI) rule by the end of year and add medical devices to the Sentinel system.

Letter from the Patient, Consumer and Public Health Coalition to Dr. Margaret Hamburg on the De Novo Process and High-Risk Medical Devices

February 28, 2012. In this letter to the FDA Commissioner, the Patient, Consumer, and Public Health Coalition expresses their concerns over the de novo approval process for high-risk medical devices, specifically a endovascular suturing system.

Comments on Proposed Rule: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices

January 17, 2012. As members of the Patient, Consumer, and Public Health Coalition, we strongly oppose the reclassification of External Pacemaker Pulse Generator Devices (Product code DTE) from class III (high risk devices) to class II (moderate risk devices). These devices are among the “pre-amendment” class III devices, which have been cleared by the less-than rigorous 510(k) process. External Pacemaker Pulse Generator Devices should remain class III devices and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices.

Letter to Dr. Margaret Hamburg, FDA Commissioner, Regarding Maintaining and Strengthening Conflict of Interest Policies for Advisory Committees

August 3, 2011. In this letter to FDA Commissioner, Dr. Margaret Hamburg, NRC and other coalition members advocate for stronger conflict of interest requirements for members of FDA advisory committees to protect patients and consumers against industry biases.