FDA Approved Record Number of Novel Devices in 2017

January 16, 2018

The FDA approved a record number of novel devices in 2017, with a total of 95 approvals — more than four times the 2009 number — up from 91 the year before.

FDA Commissioner Scott Gottlieb attributed the results to the use of the agency’s least burdensome approach, which directs agency staff and industry to use the minimum amount of information for regulatory activities.

“This policy approach is a hallmark of our efforts to help innovators generate high quality evidence that can support marketing approval as efficiently as possible,” Gottlieb said, in an FDA Voice blog post.

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