The term “guinea pig” is often used jokingly by patients who feel that their medical treatment is underdeveloped or experimental. But when it comes to the Food and Drug Administration’s fast-track approval of certain medical devices such as DePuy’s ASR XL Acetabular and ASR Hip Resurfacing implants, “guinea pig” is sometimes an apt description. The FDA often approves medical devices without requiring proper clinical testing if the manufacturer demonstrates that the new unproven device is substantially similar to an already-approved one. This process, called the 510k process, spares the manufacturer thousands of dollars in clinical testing and usually takes just ... Read More
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