Congressman Raja Krishnamoorthi, as part of his work as chairman of the Subcommittee on Economic and Consumer Policy, has turned public attention to the FDA’s mishandling of a heart device recall. Congressman Krishnamoorthi said that, “The FDA is charged with ensuring patient access to safe, effective, and high-quality medical devices, but, over multiple administrations, the agency failed to protect consumers from the dangerous HVAD System.. The agency likewise failed to adequately share knowledge of the device’s defects with other agencies. FDA must take a more proactive role in its regulation of devices that have been the subject of Warning Letters and Class I recalls, and in its communication of product defects to other agencies responsible for patient health.”
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