An article has been published in the Archives of Internal Medicine attacking the FDA’s fast track approval processes that include the 510(k) application for medical devices.
“Most medical devices recalled for life-threatening or very serious hazards were originally cleared for market using the less stringent 510(k) process or were considered so low risk that they were exempt from review (78%).”
The 510(k) process is available for use when a company claims that its product is substantially similar to another device that was previously approved. The medical device company However, a much higher percentage of 510(k) products have been found to be defective and end up getting recalled:
“Medical devices cleared through the less rigorous 510(k) pathway comprise more than two-thirds of the products that are recalled by the FDA because they could seriously harm patients or result in death. When devices that were intentionally exempt from any FDA review were added to the 510(k) devices, they comprise more than 3 out of 4 of the high-risk recalls during the last 5 years. Thus, the standards used to determine whether a medical device is a high-risk or life-sustaining product prior to approval are clearly very different from the standards used to recall a medical device as life threatening. Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy.”
Click here to read the Medical Device Recalls and the FDA Approval Process article.
To read a previous Brandi Law Firm Blog entry explaining the 510(k) process and linking to a New York Times Articla and DePuy’s actual application for the recalled ASR XL hip, click here: A Loophole Allowed the DePuy Hip to be FDA Approved without Testing
If you or a loved one has a DePuy hip, please click here to learn more about the Brandi Law Firm DePuy Attorneys.