The FDA frequently uses a medical device approval method called the 510(k) process, used to hasten a new product to market, but a growing list of reported injuries and complaints indicates the process may not be thorough enough. The 510(k) approval is a fast-track method of gaining permission from the FDA to market and sell a new medical device as long as the product is “substantially equivalent” to a product previously sold on the market. No additional clinical tests are required as long as the manufacturer can prove the new device’s similarities to another product. On May 11, an approval letter was ... Read More
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