In 1976, Congress passed the Medical Device Amendments to the Federal Food, Drug & Cosmetics Act. The purpose of this amendment was to give patients and medical professionals some level of assurance regarding the safety and effectiveness of medical devices. It also created a three-class categorization system, established regulatory pathways for bringing new devices to market and gave the FDA the power to ban a device.
The thousands of medical devices used today are largely safe and effective—improving patient care, quality of life and at times, longevity of life. However, when defective devices get to market and are used on or implanted in patients the results can be catastrophic for many people and their loved ones.
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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.
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