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.

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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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Comments on Proposed Order Regarding Sorbent Hemoperfusion 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 sorbent hemoperfusion devices because they pose substantial risks and the benefits of these devices are “unknown” and there is “limited scientific evidence” regarding their effectiveness.[1] We strongly oppose down- classifying the devices for the treatment of poisoning and drug overdose.

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Comments on Effective Date for Premarket Approval for Three Class III Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose

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 the three preamendment devices referred to in this docket 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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