October 4, 2013. We strongly support FDA’s proposed rule to classify the SWD for all other uses as a Class III device, which will require a PMA; we do not support a PDP for this device.
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NCHR Testimony on Expanded Indications for Medtronic Cardiac Resynchronization Therapy Devices
October 8, 2013. We oppose the expansion of indications for Cardiac Resynchronization Therapy Devices. We urge FDA to require more testing to prove that the benefits of these devices outweigh the risks for these new indications in general and for particular demographic subgroups.
Read More »Coalition Letter to House Leaders in Opposition to Piecemeal Funding of FDA
October 4, 2013. We are writing as public health, patient, consumer, and scientific nonprofit organizations to oppose H.J. Res 77 and any other efforts to single out the Food and Drug Administration for funding. Our organizations represent millions of patients, consumers, health professionals, and scientists who strongly support the work of the FDA and urge Congress to provide the level of appropriations the agency needs throughout FY 2014.
Read More »Patient, Consumer, and Public Health Coalition Comments on Reclassification of Cardiovascular Devices
September 17, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA’s proposed order for Intra-Aortic Balloon and Control Systems (IABP) devices used to treat septic shock or pulsatile flow generation (Other Specific Intended Uses) to remain in Class III with Premarket Approval applications (PMA) required.
Read More »Letter to Commissioner Hamburg in Strong Support of FDA’s Ban on the Imports of Ranbaxy Medical Products
September 26, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA’s ban on importing drugs manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India.
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