FDA to Hold Public Hearings on Medical Device Approval Process

The FDA has scheduled a public meeting for late this month to review review the controversial process used to swiftly approve medical devices, which some say has been overused and allowed dangerous devices to be implanted in patients.

According to a statement released last week, the FDA scheduled a public meeting for February 18. The purpose of the meeting is to discuss challenges facing the agency’s pre-market notification process, also known as the 510(k) process, which allows quick approval of medical devices if they can be shown to be substantially similar to products already on the market. Critics and studies have suggested that the FDA leans too heavily on the process for quick medical device approval, which has led to dangerous and, in some cases, deadly medical devices onto the market.

The meeting will include open comment sessions on issues involving previously approved devices, new technology and scientific evidence, FDA practices in the face of high volumes of submissions, and post-market surveillance.

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The hearings come after the release of several studies that have been highly critical of FDA’s ability to adequately investigate medical devices to ensure that they are safe for use in consumers. Two studies, published late last year, found that the FDA does not require enough clinical trials and that it often accepts suspect data at face value.

One study, conducted by researchers from the University of California and published in the Journal of the American Medical Association, found that two thirds of approved devices only went through one clinical trial before being unleashed on the market, and most of those trials involved less than 300 subjects. The other study, conducted by researchers from the FDA and Boston’s Beth Israel Deaconess Medical Center and published in the American Journal of Therapeutics, indicated that about 40% of the studies used to decide what devices are approved lack clear definitions of safety requirements.

In addition, a study by the Government Accountability Office (GAO) released in June found significant shortcomings and a heavy reliance on the 510(k) process. The GAO report identifies gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.

The meetings also come as Congress ponders what to do about a 2008 Supreme Court decision in Riegel vs. Medtronic, which determined held that the FDA approval of a medical device can make manufacturers immune from product liability lawsuits for injuries caused by the defective design of their devices. Legislation called the Medical Device Safety Act of 2009 was introduced last year to overturn that decision, but there has been no action on the bill since hearings this summer.

As a consequence of the Supreme Court decision, thousands of pending medical device lawsuits have been dismissed, including cases filed on behalf of thousands of patients injured by the recalled Medtronic Sprint Fidelis defibrillator lead.

A Medtronic Sprint Fidelis defibrillator lead recall was issued on October 15, 2007, after it was discovered that the small wires used to connect defibrillators to the heart was prone to fracture or break. Although the defective design has caused hundreds of people to suffer unnecessary shocks or caused their defibrillator to fail when it was needed to deliver a life-saving jolt, a federal judge ruled earlier this year that patient claims for medical expenses and other compensation are now barred because the FDA approved the design of the device.

The meeting will be held on February 18 from 8 a.m. to 5:30 p.m. at the Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, Maryland. Those wishing to attend the meeting or participate must register by 5 p.m. on February 12. The FDA will accept written or electronic comments until March 5, 2010. The meeting will be also webcast live at http://www.ConnectLive.com/events/fda021810.

1 Comments

  • PeterFebruary 9, 2010 at 2:46 pm

    If Congress does not act to overturn the Supreme Court ruling, I suggest that the following warning be read and handed to every potential recipient of a Class lll device. Medical Device Warning Label For All Class III Medical Devices This warning label is to advise you of potential risks associated with the use of Class III Medical Devices. The Medical Device Act of 1974 gave the Food and Dr[Show More]If Congress does not act to overturn the Supreme Court ruling, I suggest that the following warning be read and handed to every potential recipient of a Class lll device. Medical Device Warning Label For All Class III Medical Devices This warning label is to advise you of potential risks associated with the use of Class III Medical Devices. The Medical Device Act of 1974 gave the Food and Drug Administration (FDA) the authority to license and approve medical devices. Therefore, this device has been approved for general use by the FDA. Be aware, however, that the United States Congress as well as many experts familiar with the agency have stated on the record that the FDA is both underfunded and understaffed, and therefore may not have had the capacity adequately to verify all safety risks associated with this device. Also, be advised that this device has not been tested on large numbers of patients, and that it is a fact that a certain percentage of this type of device will malfunction or fail, with the potential to cause you great pain and suffering, and maybe even death. At the very least, you may need to undergo significant and costly health care follow up services to correct the problems caused by the malfunctioning device. Also, please be advised that because of a recent United States Supreme Court decision, if this device fails or malfunctions, you will not be able to sue the manufacturer of the device, unless the manufacturer has violated FDA regulations during or after the approval process. This means that either your health insurance company, you, or your family will be responsible for all costs incurred to rectify the problems caused if the device fails or malfunctions. Finally, please be advised that manufacturers of medical devices are the only companies in the country which have been granted this type of immunity from tort action. Medical Device Warning Label For All Class III Medical Devices This warning label is to advise you of potential risks associated with the use of Class III Medical Devices. The Medical Device Act of 1974 gave the Food and Drug Administration (FDA) the authority to license and approve medical devices. Therefore, this device has been approved for general use by the FDA. Be aware, however, that the United States Congress as well as many experts familiar with the agency has stated on the record that the FDA is both underfunded and understaffed, and therefore may not have had the capacity adequately to verify all safety risks associated with this device. Also, be advised that this device has not been tested on large numbers of patients, and that it is a fact that a certain percentage of this type of device will malfunction or fail, with the potential to cause you great pain and suffering, and maybe even death. At the very least, you may need to undergo significant and costly health care follow up services to correct the problems caused by the malfunctioning device. Also, please be advised that because of a recent United States Supreme Court decision, if this device fails or malfunctions, you will not be able to sue the manufacturer of the device, unless the manufacturer has violated FDA regulations during or after the approval process. This means that either your health insurance company, you, or your family will be responsible for all costs incurred to rectify the problems caused if the device fails or malfunctions. Finally, please be advised that manufacturers of medical devices are the only companies in the country which have been granted this type of immunity from tort action.

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