The Federal Food, Drug, and Cosmetic Act (FFDCA) is the law that ensures that safe drugs, cosmetics and medical devices enter the market place. In 1976 Congress passed the Medical Device Amendments of 1976, to the FFDCA, which established the framework for the current regulatory system, including the 510(k) process. Then, in 1990 and 1997, Congress passed more changes to the 1976 statute and the three enactments serve as the basis of the legislative framework for the 510(k) review process.
The law states that a moderate-risk device that is substantially equivalent, or similar, to any previously 510(k)-cleared device or any device that was on the market when the Medical Device Amendments were enacted—referred to as a predicate device—can be cleared for marketing, but with some exceptions. However when the FDA assesses the substantial equivalence of a device, it does not require evidence of safety or effectiveness. Also when a device is found to be substantially equivalent to a predicate device, the new device is assumed to be as safe and effective as the predicate, because of its similarity.
An example of the how the 510(K) clearance process is not working-are hip replacements. Every year hundreds of thousands of people get total hip replacements, surgically replacing their hip joint with a prosthetic. Implants are usually made up of a metal head that rotates inside a plastic cup. But in 2005, Johnson & Johnson's DePuy Orthopaedics introduced a new all-metal design. They maintained the new device was substantially equivalent to older models, through the 510(k) clearance process they got clearance for the hip device without conducting any clinical trials to test how it would perform in patient's bodies.
The DePuy implant caused patients many problems and almost half of all patients who got the implant required surgery to fix problems. The metal was eroding, releasing metallic particles into the blood and surrounding tissue of the joint and causing tremendous pain. After thousands of complaints and lawsuits, the device was recalled in 2010, after it had been implanted in almost 100,000 people.
This way of fast tracking medical devices into the market is leading to more and more recalls. The problem is these predicate devices were on the market before the Medical Device Amendments were never systematically assessed for safety and effectiveness. Therefore the 510(k) review process is not a good way to determine if a new medical device is safe. Even the Institute of Medicine in June 2011 concluded that the, “510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one.”
The Institute of Medicine reviewed the clearance process for medical devices and called for the 510(k) process to be eliminated altogether, because does not guarantee safe devices. They found that from 2005 to 2009, three out of four recalled high-risk devices had not been approved with clinical data, but rather had gone through the 510(k) clearance process or had been exempt from review altogether. They have advised the FDA to scrap this clearance process and set up a new more rigorous regulatory system that really protects consumers.
The 510(K) clearance process is obviously not working and unfortunately if the anti-regulatory bills such Reins, RAA and RFIA and H.R. 4078 are enacted, the medical devices industry will be allowed to speed through thousands more faulty medical devices without clinical trials and or valid testing citing new stronger regulations would be burdensome to business and the economy! Medical devices should be about sustaining and improving the quality of life of Americans and stronger consumer protections should come before profit.
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