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Aethlon Medical, Inc. Message Board

  • andy55q andy55q May 10, 2013 5:34 PM Flag

    FDA ruling... Agenda: On June 27, 2013,

    Any Relation to Cytosorbents? FDA ruling...
    Agenda: On June 27, 2013, during session I, the committee will
    discuss and make recommendations regarding the proposed classification
    of sorbent hemoperfusion systems, one of the remaining preamendments
    class III devices. The class III sorbent hemoperfusion system is a
    device intended for the treatment of poisoning, drug overdose, hepatic
    coma, and metabolic disturbances. It consists of an extracorporeal
    blood system and a container filled with adsorbent material that
    removes a wide range of substances, both toxic and normal, from blood
    flowing through it. The adsorbent materials are usually activated
    carbon or resins, which may be coated or immobilized to prevent fine
    particles from entering the patient's blood. The generic type of device
    may include lines and filters specifically designed to connect the
    device to the extracorporeal blood system. Sorbent hemoperfusion
    systems may also include the machine or instrument used to drive and
    manage blood and fluid flow within the extracorporeal circuit, as well
    as any accompanying controllers, monitors, or sensors.
    On April 4, 2013 (78 FR 20268), FDA issued a proposed order which,
    if made final, would reclassify sorbent hemoperfusion systems labeled
    for the treatment of poisoning and drug overdose class II subject to
    premarket notification [510(k)] and special controls, while sorbent
    hemoperfusion systems labeled for the treatment of hepatic coma and
    metabolic disturbances would remain class III requiring premarket
    approval (PMA) applications. The committee's discussion will involve
    making recommendations regarding the regulatory classifications noted
    above. The committee will also discuss whether the proposed special
    controls are adequate to reasonably ensure the safety and effectiveness
    of sorbent hemoperfusion devices labeled for the treatment of poisoning
    and drug overdose. The regulatory history of sorbent hemoperfusion has
    been discussed as part of a previously published proposed rule

 
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