FDA making changes in medical device approval

Posted on Apr 27, 2010

The Food and Drug Administration will soon make changes in how they approve medical devices that may require more testing. A majority of devices are approved currently through a 510(k) process which requires manufactures to prove to the FDA that their device is "substantially equivalent" to others already on the market. This usually means that are put on the market without conducting studies on actual patients.

 

The new process may require additional clinical studies to prove the safety of medical devices, meaning it would take longer for them to be approved for consumer use. While some fear this might hurt smaller companies, the American Association for Justice, a D.C.-based group of plaintiff's attorneys believes these changes will help better protect patients and ensure their safety. 





























Read More About FDA making changes in medical device approval...