The 501(k): Is it a safe process?As the number of power morcellator lawsuits climb, the GAO has agreed to investigate the FDA's 501(k) approval process. As power morcellator lawsuit numbers grow, the public has been made aware of the U.S. Food and Drug Administrations 501(k) approval process.
The 501(k)This process allows the manufacturers of surgical tools to expedite the approval process by showing that the instrument is essentially equivalent as a previously approved device. If the FDA agrees with that determination, the new device is not required to undergo the normal safety testing and clinical trial procedures.
Today, many women are wondering if the FDA missed a potentially deadly risk associated with the use of a power morcellator by allowing the tool to be approved this way. The power morcellator has been used by surgeons for several decades, but it wasn’t until recently that the FDA announced to the medical community and the public that if the device is used during a gynecological surgery, there was a chance that undetected uterine cancer could be spread through the body cavity.