Chapter 8. Artificial Intelligence-based Software
114 Regulatory Affairs Professionals Society (RAPS)
Figure 8-1. Schematic Representation of (a) The Number of FDA Approvals and Clearances Per Year
and (b) The Number of Device Authorizations by FDA Regulation Panel as of 31 December 2022
0
20
40
60
80
100
120
140
(a)
Year
1
1
1
3
4
4
5
5
6
6
7
14
15
57
392
Dental
Obstetrics And Gynecology
Orthopedic
General Hospital
Anesthesiology
Pathology
General And Plastic Surgery
Microbiology
Clinical Chemistry
Gastroenterology &Urology
Ophthalmic
Neurology
Hematology
Cardiovascular
Radiology
(b)
Number of devices
Source: Food and Drug Administration
Approvals
and
clearances
(n)
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
FDA
Regulation
panel
114 Regulatory Affairs Professionals Society (RAPS)
Figure 8-1. Schematic Representation of (a) The Number of FDA Approvals and Clearances Per Year
and (b) The Number of Device Authorizations by FDA Regulation Panel as of 31 December 2022
0
20
40
60
80
100
120
140
(a)
Year
1
1
1
3
4
4
5
5
6
6
7
14
15
57
392
Dental
Obstetrics And Gynecology
Orthopedic
General Hospital
Anesthesiology
Pathology
General And Plastic Surgery
Microbiology
Clinical Chemistry
Gastroenterology &Urology
Ophthalmic
Neurology
Hematology
Cardiovascular
Radiology
(b)
Number of devices
Source: Food and Drug Administration
Approvals
and
clearances
(n)
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
FDA
Regulation
panel