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More Information on the Device Review Process

Comments on Sorbent Hemoperfusion, Cranial Electrotherapy Stimulators, and Transilluminators for Breast Evaluation

May 6 2013

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Public Citizen opposes the FDA’s proposed order reclassifying sorbent hemoperfusion devices into Class II for the treatment of poisoning and drug overdose, based on concerns that the devices carry severe, life-threatening risks, and insufficient clinical evidence exists to determine whether they are effective compared with alternatives. We support the FDA’s proposal to retain these devices in Class III (requiring premarket approval) for the treatment of hepatic coma and metabolic disturbances. We also support the FDA’s proposal to retain cranial electrotherapy stimulators and transilluminators for breast evaluation in Class III, as safety and efficacy for these devices has also not been established.

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