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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NCHR Comments on Proposed Order Regarding Transilluminator for Breast Evaluation

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 Transilluminator for breast evaluation 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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