Personal Injury News

Flaws in FDA Medical Device Approval Process (Part 1)

Is the FDA Keeping You Safe From Harm?

The DePuy Orthopaedics ASR XL Acetabular hip is an example of a medical device approved by the Food and Drug Administration through an expedited system known as the Premarket Notification Approval Process or more commonly “501(k).”The DePuy hip recall call into question the FDA’s effectiveness in keeping the public safe from suffering preventable injuries.

This method allows manufacturers to submit a device for approval without testing by comparing it to a previously approved “predicate” device, which is characterized as “substantially similar.” According to a study published in the Archives of Internal Medicine, approximately 80 percent of medical devices that have been recalled were approved via the 501(k) route and were never clinically tested in full with human beings.

DePuy sought approval of the ASR system through the 501(k) process, saying the hip was “substantially equivalent” to three other products. Each of those products was also approved via the 501(k) process. Critics have called this situation “predicate drift.” Each generation of product approved via the 501(k) procedure gets farther and father away from devices that actually were subjected to clinical trials.

If you have a DePuy ASR hip implant it is imperative to speak with a hip recall lawyer immediately to ensure that your rights are protected. (800) 707-1210

Comments are closed.