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Companies are Not Liable for Their Defective Device if Given FDA Approval

Companies are Not Liable for Their Defective Device if Given FDA Approval

DePuy Knee Replacement | Fresenius GranuFlo Dialysis | Metal-on-Metal Hip Implant | Defective Hip Implants | Lawyers, Lawsuits | Side Effects: Hip Replacement Pain, Delayed Side Effects, Symptoms, Premature Failure | Premature Failure, Faulty Components, Contaminated Device

Attorney Gary Falkowitz of Parker Waichman explains the process in which the FDA (Food and Drug Administration) approves medical products including devices and prescription drugs.

The FDA agency takes each product and first places it in one of three classes based on the risk they pose to the public. The product then goes through one of two different approval processes. The most stringent is the PMA (Pre-Market Approval) in which the company has to thoroughly test the device and that may be on human or animal test subjects. The FDA will not allow products onto the market who have not met this approval. The only other option a company has is a process known as 510k. In this scenario, the company is not required to test the product if it can prove that their product is very similar to one already on the market that has already been approved. Watch this video now to learn more.

To learn more about defective medical devices, I encourage you to watch the video above and to explore our educational website at If you have legal questions, I want you to call me at (800) 800-9797. I welcome your call.


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