Efficiency and speed is valued when bringing new medical devices to the market, but what remains relatively unknown are the risks inherent in the current U.S. Food and Drug Administration (FDA) approval process. The 510(k) process, outlined in the Federal Food, Drug and Cosmetic Act, allows the FDA to give market approval to medical devices that are found to be substantially equivalent to an already approved medical device, without performing any human clinical trials. Through this process, not only can a medical device hit the market without the performance of any safety trials, but it can be approved by being deemed substantially equivalent even to a device that has previously been recalled.
The current Transvaginal Surgical Mesh litigation highlights the potential flaws of this system. In this litigation, lawsuits are being filed against multiple manufacturers of mesh products, most of which were approved and brought to the market through the 510(k) process. The predicate medical device to which these products were found substantially equivalent was in fact recalled in 1999. As a result, multiple mesh products have gone to the market, approved solely based on being deemed substantially equivalent to a recalled product. Several mesh products have since been pulled from the market due to safety concerns, but not before thousands of women were exposed to them and are suffering from the resulting injuries. This is a prime example of the risk of putting substantially equivalent devices on the market without performing clinical trials, especially when that original device was recalled and found unsafe for patients. These concerns led the FDA to begin an internal review of the 510(k) process.
The FDA commissioned the Institute of Medicine (“IOM”) to review the current 510(k) process, and in July 2011 the IOM determined that this system was flawed and suggested that a new regulatory framework be created to ensure safety and effectiveness going forward. Though the FDA determined that the process as a whole did not need to be eliminated, it did make plans to strengthen and reform the 510(k) process and created new guidance for the industry and FDA staff about the process.
Some members of Congress are not leaving it up to the FDA to fix this problem. Earlier this year, U.S. Congressman Edward Markey (D-Massachusetts) addressed this issue head on and introduced H.R. 3847, the Safety of Untested and New Devices Act of 2012. This legislation seeks to amend the Federal Food, Drug and Cosmetic Act to prevent medical devices from being marketed based on being found to be substantially equivalent to a device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety. H.R. 3847 was not incorporated in the Prescription Drug User Fee Act recently passed by Congress, but has been referred to House Committee with its outcome still to be determined.
While the ability to bring medical devices into the market efficiently is beneficial, it should not be done by compromising the safety of those who will ultimately use the product. A balance must be struck between swiftly marketing medical devices and ensuring patient safety. Whether the FDA really addresses the issue or whether Congress intervenes with a real fix remains to be seen.
Photo Credit: Phalinn Ooi
 Institute of Medicine of the National Academies, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 years, July 29, 2011, http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx.
 Safety of Untested and New Devices Act of 2012, H.R. 3847, 112th Cong. (2012).