On November 17, 2011, CBS 11 News broadcast a news segment regarding the 510(k) rule, a medical device approval process used by the F.D.A. to fast-track products into the market. The news segment focused on the 510(k) process used to approve the DePuy ASR XL hip system, which was recalled by DePuy Orthopaedics, Inc. in August 2010.
The 510(k) rule permits the fast track of a new medical product into the market if it is “substantially equivalent” to a similar device that is already in use and has been deemed effective. Through the 510(k) rule, the DePuy ASR XL hip system entered the U.S. market in 2005 without undergoing clinical testing to study its effectiveness and safety. Patients with the failed DePuy hip implant device have reported elevated levels of chromium and cobalt metals in the bloodstream and component loosening. There have been approximately 2,000 DePuy ASR cases filed since the device was recalled late last year.
In light of the growing medical problems faced by patients who have received failed medical devices like the DePuy ASR hip implant, the Institute of Medicine is now asking the F.D.A. to revise the 35-year-old 510(k) rule. Proponents of the 510(k) rule argue that the process allows for a shorter wait time for approval of new medical devices that are only subtly different to products already on the market. The F.D.A.’s decision regarding the 510(k) process is expected by next year.
See the full news segment from CBS 11 News at: