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How FDA Approved Hysterectomy Tools It Now Disfavors
The Wall Street Journal (online registration required): The FDA over two decades cleared at least 10 such morcellators from various companies through a streamlined process that lets a device maker seek approval by showing a product is similar to an already-approved device.
Congress created that expedited process in 1976. The FDA used it to review 99% of about 3,000 new medical-device applications it cleared in the 2013 fiscal year. In contrast, the FDA has recently approved roughly 30 new drugs each year, after stringent reviews that usually require controlled clinical trials that can take years.
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