December 12, 2013. Stair-climbing wheelchairs are have been considered high risk – Class III – and have been required to submit studies of safety and effectiveness under the PMA review process. The proposed order would reclassify stair-climbing wheelchairs into Class II indicating moderate risk, and reviewing it through the 510(k) process.
Read More »On Health Policy
NCHR Testimony on Classification of Spinal Sphere Devices
December 12, 2013. For classification of spinal sphere devices, we support FDA in considering a Class III designation for these devices.
Read More »Letter in Support of the Whistleblower Protection Act
November 19, 2013. As members of the public health community, we write to urge you to support the Warner-Collins-Kaine-Grassley amendment to the National Defense Authorization Act for FY 2014 (NDAA, S. 1197).
Read More »NCHR Testimony on Premarket Approval of Nucleus Hybrid L24 System Cochlear Implants
November 8, 2013. Medical devices should not be approved on the basis of wishful thinking.
Read More »Comments on the NIH Office of Disease Prevention Strategic Plan for Fiscal Years 2014-2018
November 22, 2013. While improvement in public health measures can be more challenging to assess, and requires a longer time period to evaluate, the goal of prevention research should be focused on measurable health outcomes, and not simply on the number of grants or scientific publications. A more explicit identification and prioritization of research goals would increase confidence that meaningful public health results will be achieved where they are most urgently needed.
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