As many citizens of North Carolina are exposed to the dangers of defective medical devices being placed on the market, legislation is being introduced to keep such devices off of the market. The Safety of Untested and New Devices Act of 2012 gives the FDA a variety of powers to reject proposed medical devices from being introduced to the public.

The legislation is in part a response to the number of recalls of such devices in recent years. In particular, the metal on metal hip implant devices, bladder slings and synthetic surgical mesh products earned enough notoriety that lawmakers felt it essential that a process be put in place to prevent such products from being introduced in the future.

Prior legislation has allowed a number of medical devices to be introduced if they were "predicates" of devices already approved. What was meant by the term "predicates" was that the new product was substantially equivalent to another medical device on the market. Unfortunately, such legislation merely resulted in less regulation of devices being introduced as the phrase "substantially equivalent" became watered down as more and more devices were approved under this scheme.

It is thought that approximately 99 percent of medical devices have been approved through the predicate scheme that likely received little to no clinical trial or testing. That so many devices are on the market understandably explains why so many injuries have resulted from the use of such medical devices. Individuals injured while using such products do deserve compensation and may want to consider contacting attorneys experienced in product liability matters in an attempt to receive payment.

The new legislation would give the FDA greater authority to review applications for such predicates and have these removed for safety reasons. It would also require reporting by the medical device manufacturers in that injuries occurring from use of such predicates would need to be reported to the FDA.

Source: Safety Research and Strategies, Inc., "Lawmakers Try to Close FDA Loopholes," Feb. 8, 2012