FDA to overhaul more than 40-year-old process for approving medical devices that some say puts consumers at risk
  • 2018-12-11
  • 97

 

 

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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