FDA to overhaul process for approving medical devices that some say puts consumers at risk

Posted By American Med Spa Association, Wednesday, November 28, 2018

The Food and Drug Administration is overhauling the most common way medical device manufacturers bring their products to market in an attempt to advance new technologies.

Since 1976, manufacturers have been able to pursue an expedited approval process if they could prove new products were substantially equivalent to those that were grandfathered in when Congress established the pathway, known as 510(k).
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