The Food and Drug Administration (FDA) has once again been put in the limelight for the continuing controversy regarding their 510(k) premarket notification process. The mounting complaints against DePuy for the complications resulting from the use of their products and which has led to several DePuy ASR hip lawsuits have triggered anew calls for the elimination of this process.
To recall, DePuy’s hip replacement systems consisting of the ASR XL Acetabular System and the ASR Hip Resurfacing System were made available in the US in 2005 after getting a clearance from the FDA. This was done even without going through extensive clinical tests through the 510(k) prenotification program of the agency. Under this process, products may be cleared for distribution as long as these are substantially equivalent to predicate devices or products that have undergone testing.
While concrete actions are still needed regarding this issue, it is encouraging to note that the FDA is undertaking steps to address the problems on hip replacement implants. It has proposed new regulations that require manufacturers to conduct tests for the product’s safety and effectiveness before getting an approval.