Investigation Reveals Lack of Testing for Medical Devices
Tens of millions of Americans living with medical devices in their bodies assume that these devices have been tested for safety and efficacy before being marketed, but an article reports that this may rarely be the case. In fact, the article reports that most implants and other high-risk devices require only that manufacturers file paperwork with the FDA and pay the necessary user fee in order to begin selling the particular product. Even where the FDA mandates advance safety studies for particular high-risk products, certain government rules permit them to be sold based on studies involving a smaller sample size and less rigorous methods in comparison to studies required for prescription drugs.
In particular, the article reports that the current framework presents a number of problems and issues, including the absence of a systematic way for authorities, researchers and patients to identify problems with devices to ensure consumer safety. As a result, a Panel from the Institute of Medicine has urged the FDA to overhaul its device regulatory system to better ensure patient safety both before and after these products are placed on the marketed.
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