October 4, 2012. Members of the Patient, Consumer, and Public Health Coalition strongly support the FDA’s proposed rule to require Premarket Approval Application (PMA) for the Class III preamendments device Shortwave Diathermy (SWD) for all other uses except for the treatment of malignancies. However, we oppose FDA’s proposal to allow a Product Development Protocol (PDP) instead of a PMA for this device because PDPs are for devices where a sponsor comes to an “early agreement with FDA as to what would be done to demonstrate the safety and effectiveness of a new device.”
Read More »On Health Policy
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.
Read More »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.
Read More »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.
Read More »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.
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