While the U.S. Food and Drug Administration (FDA) was developed with the intentions of protecting consumers from dangerous and fraudulent products, recent concern has broken out as to whether or not their regulatory efforts are sufficient enough. Subsequently, the FDA is being blamed for the introduction of faulty and defective medical devices to the U.S. market. Consumer rights activists believe that the current regulatory policies are not strict enough, and therefore warrant revision. Consumers Union, the advocacy arm of Consumer Reports, recommends that Congress make the FDA require that implants and other “life-sustaining” devices be tested at least as rigorously as drugs.
According to a recent Consumer Union report, there are a lot of medical devices that have been given approval by the FDA, but have never been tested for safety. The report acknowledges that manufacturers often are required to do nothing more than file paperwork and pay a user fee before bringing their products to market.
Consumer Reports emphasizes the fact that several devices, over recent years, have exhibited significant problems and demonstrated a propensity for failure. Of particular concern was surgical mesh, the Lap-Band and metal-on-metal hip replacements. Each of which have been the subject of increased criticism for their link to adverse health complications. However, each were given approval by the FDA’s 510K provision. In particular, the recent Consumer Union report acknowledged this 510K provision as the culprit for allowing these dangerous devices on the market.
“510K” refers to the Medical Device Amendment (MDA) of 1976 statutory provision from which FDA granted itself the authority to make exceptions for post-1976 medical devices that the Agency deemed “substantially equivalent” to older products. Essentially, the process works like this: if a manufacturer wants to market a new medical device that falls into a category FDA deems is of “low risk” (e.g., surgical mesh), that product can be marketed without the usual pre-market testing and without formal FDA approval so long as the manufacturer can show that the device is relatively close in design and intended use to a product that is already being marketed. That is so, even if the “old” product was itself never tested or approved by FDA.
What’s worse is that, as it happened, the vast majority of products introduced to the market since 1976 have fallen into this 510K “loophole,” so that most medical devices sold today have never been tested in compliance with the pre-market testing requirements of the MDA, nor have they been formally “approved” by FDA.
In an attempt to reduce the amount of dangerous products that this provision allows on the market, Consumers Union has called for Congress to require subsequent testing of medical devices to be more rigorous. Furthermore, Consumer Union has motioned to put an end to the “grandfathering” of high-risk devices.
According to Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital, “the bottom line is that new devices, particularly lifesaving devices, need to be tested before they are put in people.”
Also agreeing with the recent Consumer Union report, is Senator Amy Klobuchar and Rep. Erik Paulsen. “I will continue to work to ensure we have the processes in place to promote safe, pioneering technologies that help save lives, and create good jobs in Minnesota,” said Klobuchar.
Said Republican Paulsen: “Above all else, we must ensure that medical devices are safe — period. I am confident that we can improve the efficiency and effectiveness of the medical device approval process as well as solidify our nation’s position as a global leader in innovation.”
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