Making FDA Accountable For The DePuy Hip Replacement Recall
There is a belief that whatever medical product available for the public to use would be safe. The Food and Drug Administration is the branch of our government that would make this belief true. Making the product go through necessary tests will be part of DePuy’s duty. Nevertheless, it must be noted that the tests will be done by the manufacturer of the product. The FDA would only do its work by determining if the product’s advantages exceed its risks.
A time can happen when a product can be available in the market without going through certain tests . The premarket notification also known as 510(k) makes this possible because the product’s quality is determined by the products already approved by the FDA that came through the same employer. The manufacturer will have a lot of benefits upon gaining a premarket notification. This is because acquiring a premarket notification clearance will only take the manufacturer six months to wait and will also cost less. This happens to be quite beneficial to the manufacturer but works for the public in an opposite way. There is a big chance that the product will fail. Making the product go through necessary tests will be the only way to assure quality.
DePuy’s ASR XL Acetabular System and the ASR Hip Resurfacing System were failed products released to the market because of a premarket notification clearance. The previous products DePuy has created were compared to these products as having the same quality. The public can suffer from this if the product happens to be defective.
Now, the people affected of the recent DePuy hip replacement recall could not have suffered if only the implants went on the necessary tests to prove its quality which has now resulted to a lot of people filing a DePuy lawsuit. If you are one of those individuals that have suffered, it is best to go to a lawyer to discuss your case. To make FDA be wary on this situation is only natural.
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