May 22, 2013. We need to get a better sense of what the real benefits are, not just 5 minutes or 20 minutes more of uninterrupted sleep, but the actual functioning of a person on the next day.
Read More »On Medical Treatments & Products
NCHR Testimony on Nonthermal Shortwave Diathermy Devices Classification
May 21, 2013. Testimony of Caitlin Kennedy, senior fellow, on nonthermal shortwave diathermy devices classification, FDA Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, on May 21, 2013
Read More »NCHR Testimony of on Pedicle Screw Spinal Systems
May 22, 2103. Pedicle screw systems are used to stabilize the spines of patients who need spinal fusions to correct spine injuries, deformations, or degeneration. Dr. Yttri pointed out the lack of clear clinical evidence that pedicle screw systems are beneficial for patients and how the FDA should require clinical testing before approving new devices.
Read More »NCHR Comments to the FDA on Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis
May 8, 2013. The National Research Center for Women & Families and the TMJ Association oppose the reclassification of Temporary Mandibular Condyle prosthesis, a preamendments class III device, into class II. The proposed special controls are not rigorous enough to provide a reasonable assurance of the device’s safety and effectiveness.
Read More »Comments on Proposed Order Regarding Cranial Electrotherapy Stimulator Devices
May 6, 2013. As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA requiring the premarket approval (PMA) process for cranial electrotherapy stimulator devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness.
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