35 years ago, Congress passed the Medical Device Amendments of 1976 which established the framework of the current FDA regulatory system.  This set of laws included one commonly known today as the 510(k) process.  This 510(k) process allows medical devices, from tongue depressors to pacemakers to artificial hips, to be cleared for sale in the United States if the manufacturer shows that it is substantially similar to any device already on the market.

Recently, it has become clear that many medical devices cleared through the 510(k) process are essentially untested before being sold and then later are found to be defective and unsafe.  The Brandi Law Blog has has discussed this matter before:

Government Accountability Office Criticizes FDA Fastrack Process

78% of Recalled Medical Devices were Approved by the FDA’s Fasttrack Process

A Loophole Allowed the DePuy Hip to be FDA Approved Without Testing

In July 2011, the Institute of Medicine of the National Academies (IOM) published a report discussing the 510(k) process and whether or not is should be revised.  The IOM is an independent nonprofit organization established in 1970 with the mission to serve as adviser to the nation to improve health.  In its report, the IOM came to some concerning conclusions:

1. The 510(k) clearance is not a determination that the device is safe or effective.
2. The 510(k) clearance process is not reliable to screen devices for their safety and effectiveness.
3. The 510(k) process is flawed based on its legislative foundation and unfixable.
4. Rather than trying to fix the 510(k) process, the FDA should develop a new program that would provide a reasonable assurance of safety and effectiveness of medical devices.

Click here to read the entire IOM report – Medical Devices and the Public’s Health:  the FDA 510(k) Clearance Process at 35 Years

On August 10, 2011, the New England Journal of Medicine published an article discussing this topic as well, linking the 510(k) process to the current issues with the DePuy ASR XL artificial hip.  In that article, the Journal applauds the IOM’s findings and supports its recommendation that the 510(k) process be replaced with one that evaluates the safety and effectiveness of medical devices before they hit the market.  Unfortunately, it appears that the FDA does not intend to implement the suggestions of the IOM to fix this process.

Click here to read the entire New England Journal of Medicine Article:  Medical Devices – Balancing Regulation and Innovation

If you or a loved one has a DePuy hip, please click here to learn more about the Brandi Law Firm DePuy Attorneys.