Patients in Tennessee should be aware of an effort by the Food and Drug Administration (FDA) to tighten guidelines regarding a program for “fast-tracking” medical device approval. On July 28, 2014, the agency communicated to its own personnel and to the medical device industry new standards regarding its 510(k) program.
Since the 1980s, this program has allowed medical device companies to bypass certain clinical trials and testing requirements that normally accompany an effort to garner FDA approval for a new medical device. Specifically, if a medical device is claimed to be “substantially equivalent” to one that has been previously tested and approved, elements of the rigorous testing process can be bypassed.
In the past, the program has been so controversial that some have called for its suspension. In 2011, Dr. David Challoner, the chairman of the Institute of Medicine, called for an end to the program. At the time, Dr. Challoner suggested that medical device manufacturers had succeeded in pushing the FDA to promote expediency over public safety. This resulted, he said, in certain defective medical devices being used in many patients. Numerous defective medical device lawsuits have been filed as a result.
The 510(k) program commenced decades ago as a well-intentioned effort to save both the FDA and the medical device industry time and expense when rather innocuous items like tongue suppressors were at issue. A minor change to materials or design no longer required a manufacturer to seek a new FDA approval with its attendant clinical trials and other robust testing procedures. Unfortunately, medical device manufacturers were allowed to continue to expand the use of the program until much more elaborate devices like defibrillators and artificial hip joints were involved.
The new FDA guidelines published on July 28, 2014, seek in part to address past abuses of the program in Tennessee and across the nation. Now, the FDA specifically requires that substantial equivalence can be asserted only in situations where the new device is 1) to be used in the same fashion as the predicate device, and 2) the new device has the very same technological qualities as the earlier device. When there are technological changes, the manufacturer will be required to address any questions of safety that such changes may bring about. Clinical and/or scientific data may be required to support any such claim.
Injured by a Defective Medical Device in Tennessee?
For those that may have been impacted by defective medical devices, Attorney Group for Tennessee stands ready to offer assistance. If either you or a loved one has been potentially harmed by a defective medical device, such as transvaginal surgical mesh or a hip replacement, please contact us. We can help answer your questions and connect you with an affiliated attorney who can help you through the legal process. Contact us today for a free consultation.