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Table 1 Novel, high-risk cardiovascular devices approved by the US FDA between 2005 and 2020

From: Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA

Novel approvals (N = 156)

Number (%)

FDA review pathwaya

 

 Priority

16 (10)

 Standard

140 (90)

Life-sustaining designationa

 Life-sustaining

84 (54)

 Non-life-sustaining

72 (46)

Implantable designationa

 

 Implantable

123 (79)

 Non-implantable

33 (21)

Combination producta

 

 No

127 (81)

 Yes

29 (19)

Company management

 

 Public

96 (62)

 Private

60 (38)

  1. FDA US Food and Drug Administration
  2. aFDA designation