According to the United States Institute of Medicine, it is time for the Food and Drug Administration to make a few changes after 35 years of the same methods. In a recently released report, the group has hopes of changing the way the agency regulates medical devices.

Most medical devices make it to the market through the fast-track 510(k) process of approval, which is the vanguard of pending discussions.

The document requested by the US Food and Drug Administration is anticipated to recommend that medical devices, including pacemakers and artificial joints be put through a more arduous approval process before they are permitted release on the market.

According to Section 510(k) of the Food, Drug and Cosmetic Act, medical device manufacturers are required to register and notify the Food and Drug Administrat

ion that they intend to market that medical device a minimum of ninety days prior to action. This is referred to officially as Premarket Notification, or PMN.

This way, it is possible for the Food and Drug Administration to determine if the medical device is comparable to a medical device that is already in place in one of the classification categories. New medical devices that are unclassified will still be identifiable.

To be more specific, medical device manufacturers have to submit a premarket notification to the FDA, which states their intentions to introduce a new medical device into commercial distribution or to reestablish a medical device that has been altered significantly in a way that effectiveness and safely may have been affected. These modifications and changes may relate to material, design, chemical composition, manufacturing process, energy source or the intended use of the device.

According to the deputy director of Public Citizen’s Health Research Group Dr. Michael Carome, “FDA’s oversight and review process is too weak and needs to be strengthened. We believe that the process for approving devices under the 510(k) program frequently is deficient because of the application and the loose interpretation of what it means to be ’substantially equivalent to a predicate device.”

photo credit: mullica

Trees are good for your health – they suck up carbon dioxide and release oxygen, help reduce greenhouse gases and provide welcoming shade during the summer. But those aren’t the trees that have recently been in the news for helping to improve the health of many Americans. This time it’s family trees that are up for discussion – and electronic ones, at that.

Importance of Knowing Your Health History

The importance of knowing your family medical history can’t be emphasized strongly enough, according to Acting Surgeon General Steven Galson, whose office has been in charge of a new initiative to promote the use of a website where users can grow an electronic family tree to find out where their health risks lie.

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From cancer treatment to breast reduction, insurance companies offer a wide array of coverage for those needing medical treatment. One such procedure that insurers will not cover is a lobotomy. Dr. Walter Freeman was the doctor responsible for bringing the lobotomy procedure to the United States in the 1930’s. It was used to potentially remedy mental illness and other disorders of the brain however the lobotomy procedure did not see much success. There are a few reasons today why insurance companies refuse to cover this type of medical procedure.

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The phrase “snake oil” originally referred to a traditional Chinese medicine used to treat joint pain. When it was popularized in the U.S., during the time of building the Transcontinental Railroad, patented medicine salesmen—angry at the fact that snake oil medicines were cutting into their profits—used the term pejoratively to refer to medicines that were sold by quacks.

The term snake oil then became a generic name for many of the future medicines marketed as panaceas or miraculous remedies. In reality the vast majority of these medicines were nothing more than the equivalent of sugar pills. Follow us on a journey as we take a look at some of history’s most charming snake oil labels.

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