November 27, 2018

FDA plans big changes to 510(k) pathway

By: Judy Mathias

Editor’s Note

The Food and Drug Administration (FDA) on November 26 announced that it plans to modernize its 510(k) approval pathway by pushing device manufacturers to rely on predicate devices that are not older than 10 years.

Under the existing pathway, manufacturers can pursue expedited approval for devices that are substantially equivalent to decades-old technologies.

The FDA will release a list of technologies that are based on older comparisons.


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