Why Is This Happening Now?
Back in 2002, Congress passed Medical Device User Fee and Modernization Act (MDUFA), which gives the FDA the authority to collect fees from the medical device industry, the pharmaceutical industry and other regulated industries.
This year, Congress must pass a law reauthorizing these fees. There will be intense negotiations between the FDA, Congress and the device industry. Changes to the device approval process will be a significant part of these negotiations.
The current process has numerous weaknesses, evidenced by the numerous recent recalls of devices on the market and the thousands of injuries and deaths caused by defective devices. If anything, the approval process should be strengthened, not weakened.
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FDA Loophole Puts Patients’ Lives at Risk
Tell Your Senators to Close the Loophole
Current law provides for “fast track” approval of new medical devices that may be similar to existing devices — even if the existing devices have been recalled from the market due to dangerous design defects.
This process — called 510(k) — has become a loophole for risky and ineffective devices pass to through.
Under the 510(k) process, the Food and Drug Administration is required to approve any device that is “substantially equivalent” to a previously approved device — even when the new product repeats an earlier model’s dangerous flaws!
The outcome is predictable and tragic: Many patients who were treated with the defective devices suffer preventable injuries, even death.
Tell your senators to close the loophole by ensuring that potentially flawed devices get the thorough review they deserve.
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