A bill has been introduced in Congress to give the U.S. Food and Drug Administration more authority in the medical device approval process to keep potentially harmful products from coming to market. The Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act), if passed and signed into law, would allow the FDA to reject a manufacturer’s application for a new medical device based on the approval for a similar product already in the marketplace if that device has been subject to a safety recall. The sponsors of the bill are Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rep. Rosa DeLauro (D-Conn.).
This legislation is in response to the recent recalls, civil lawsuits and warnings about defective medical devices, such as metal-on-metal hip implant devices and synthetic surgical mesh products. To date, as we have reported, two metal-on-metal total hip replacements and one metal-on-metal hip resurfacing system have been recalled in the U.S. in 2008 and 2010 because they had a high rate of replacement in patients.
New research presented last month at the American Academy of Orthopaedic Surgeons annual meeting in San Francisco shows that these faulty hip joints pose adverse health effects for some patients even after they are removed. In addition, the FDA has issued warnings about so-called bladder slings, surgical mesh products used to repair organ tears.
As we have reported previously, the vast majority of medical devices are approved for sale in the U.S. based on a manufacturer’s claim that the new product is “substantially similar” to an already approved device. Although medical devices have been regulated by the FDA since 1976, rules designed to streamline the approval process, called Pre-Market Notification – or 510k – have allowed designs and materials combinations to enter the marketplace with no clinical testing or proof of efficiency. Under Pre-Market Notification, or 510k, new medical devices that were “substantially equivalent” to devices – called “predicates”- could be approved if the predicate was already on the market by 1976.
Many new versions of older Class III devices, the most invasive and life-supportive devices, such as hip implants, were grandfathered by the Medical Device Amendments. Therefore, they are regulated under the 510k process until the FDA can complete a more rigorous scientific review, called a Pre-Market Approval (PMA).
In 2002, as a result of the aggressive deregulation efforts by the Bush Administration, a further loosening of the 510k process was allowed. The FDA was directed to take “the least burdensome approach to medical device regulation,” and the definition of “substantially equivalent” now included products made using different materials and mechanics than the predicate device. That has created lots of problems for persons having a need for certain medical devices.
Predicates no longer had to be in the marketplace in 1976. Any device already cleared – either by 510k or PMA – applied. In reality, 510k became the de facto route to FDA approval, with 99 percent of all devices approved under this scheme. As a result, the regulations allowed patients to be exposed to devices that had never been subjected to clinical trials, testing or any standards.
The FDA gives wide latitude to what may be considered substantially equivalent. A medical device manufacturer could submit a 510k if the device has a different intended use than the predicate. It can seek approval under 510k “if there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness.” Many clinicians and public health advocates have been highly critical of the 510k process, and rightfully so. They have documented the increased risk of patient harm created by the release of problematic health devices.
The SOUND Devices Act would give the FDA the authority to review and reject a 510k based on a predicate that has been recalled or is being removed from the market for safety reasons. It would require companies to inform the FDA if any of the new device’s past predicates have caused serious harm and to explain how the new device would not cause the same harm. Under this provision, the FDA would have to maintain a publicly accessibly database so that companies can determine if a device can be used as a predicate.
The bottom line is that the SOUND Devices Act would strengthen recall reporting requirements. If you need more information on medical devises, contact Navan Ward, a lawyer in our Mass Torts Section. Also, if you agree that the public should be protected, and that medical devices should be safe for use, contact your members of Congress and ask them to support this badly needed legislation.
Source: Public Citizen
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