September 11, 2013. We strongly oppose the reclassification of External Pacemaker Pulse Generator Devices from class III (high risk devices) to class II (moderate risk devices). We urge you to recommend that these devices should remain class III and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices and because clinical data are urgently needed to provide useful information to health professionals about the benefits and risks.
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NCHR Testimony at FDA on Reclassification of External Cardiac Compressors
September 11, 2013. We strongly oppose the proposal to reclassify External Cardiac Compressors Class III devices to Class II (special controls).
Read More »Comments on Proposed Order on Reclassification of Stair-Climbing Wheelchairs
September 10, 2013. As members of nonprofit patient, consumer, and public health organizations, we oppose the FDA proposed order that will reclassify stair-climbing wheelchairs (a Class III device, indicating high risk) into Class II (moderate risk). This change in classification would result in greater risk for some of our nation’s most vulnerable consumers.
Read More »Patient, Consumer and Public Health Coalition Comments to FDA on Ensuring Access to Adequate Information on Medical Products
September 9, 2013. We are writing to express our strong support for the FDA’s efforts to improve how it communicates information on medical products to all Americans, and especially underrepresented subpopulations.
Read More »Letter to the CA Bureau of Electronic and Appliance Repair in support of Improved Flammability Standards for Furniture
September 3, 2013. As a nonprofit organization dedicated to improving public health, the National Research Center for Women & Families strongly supports the proposed revisions of California’s flammability standards for upholstered furniture and other products.
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