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• NHTSA Funds Development of Alcohol Measuring Start Button in Cars
• Study Links Sports-Related Brain Injury with Brain Disease
• Anderson County School District 5 Requires Students to Take "Alive at 25" Course
• Volvo XC90 Named as Least Expensive Car to Insure in the United States

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• South Carolina Legislature Considers Enhanced Safety Measures for ATV's...
  Posted on 4/5/2011
• Boat Capsizes, Seven Rescued...
  Posted on 9/9/2010

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• Dirk Derrick's book "3 Feet From Disaster" gives tips on how to purchase the right car insurance and how to protect you and your family.
• Dirk Derrick's book "3 Feet From Disaster" gives tips on how to purchase the right car insurance and why the insurance companies wouldn't want to sell you more coverage.

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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. 

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