510(k): The FDA’s Loophole to Cutting Corners

The FDA’s 510(k) fast-track program is causing more problems than it solves. Did you know that 32 million Americans have at least one medical device implanted? As the main governing regulatory body of drugs and medical devices, countless Americans trust their lives to the Food and Drug Administration (FDA) every day. The FDA acts as a gatekeeper, as it states the agency is “responsible for protecting the public health by ensuring the safety” of products such as medical devices, the reality is people are getting hurt by the same organization that claims to protect. What is the 510(k) Fast Track Program? Americans want solutions, and they want them fast. In an effort to reduce the time it takes for a medical device to reach the public, the FDA uses a fast-track premarket approval process known as the 510(k) Fast Track Program. Through this process, the manufacturer must demonstrate that the medical device is safe and effective enough to be marketed without…

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