Should The FDA Create A New Process For Approving Artificial Devices?

 Posted on December 19,2012 in Defective Medical Devices

Every year approximately one million people receive an artificial knee or hip, making it a $7 billion dollar industry. However, many patients eventually have to have a second surgery because the original replacement was faulty or recalled.

Because of this, a panel of medical experts believes the FDA should create a new process when approving devices. The current review is called a 501(k) and helps approve products that are similar to others already approved and on the market. The average time for a new device to be approved is 10 months—which the panel thinks is too short.

It was suggested that instead of the streamlined review, the FDA should mandate each device maker proves the moderate-risk (also known as Class II) products are safe and effective. Although this complex process may take more time, it could prove beneficial. Annually, 83 percent of the 700 devices recalled are Class II.

The top lobbying group in the artificial device industry does not believe a change is necessary. The FDA also states that the 501(k) is effective, mentioning in this ABC article that it has brought about a “robust medical device industry in the U.S. and…lower-risk devices to the market for patients who need them.”

They have, however, decided to hold a public meeting in order to discuss possible changes.

You can inform yourself by researching new options, as well as learning about recalled products. You can find a list of FDA recently recalled items here, or look up a specific item here.

If you've received a device that has been recalled, you should immediately contact an experienced and competent lawyer. The Law Offices of Newland & Newland has been serving Chicagoland for over 15 years. With six office locations in Northern Illinois, they are easily accessible and able to work with you to obtain the best outcome. Contact them today to get started.