Chapter 8. Artificial Intelligence-based Software
134 Regulatory Affairs Professionals Society (RAPS)
3. Perrault R, et al. The AI Index 2019 Annual Report.
AI Index Steering Committee, Human-Centered AI
Institute, Stanford University, Stanford, CA. Published
December 2019. Accessed 13 June 2023. https://hai.
stanford.edu/sites/default/files/ai_index_2019_report.
pdf
4. Zhang D, et al. The AI Index 2022 Annual Report.
AI Index Steering Committee, Stanford Institute for
Human-Centered AI, Stanford University. Published
March 2022. Accessed 13 June 2023. https://aiindex.
stanford.edu/wp-content/uploads/2022/03/2022-AI-
Index-Report_Master.pdf
5. Maslej N, et al. The AI Index 2023 Annual Report,
AI Index Steering Committee, Institute for Human-
Centered AI, Stanford University, Stanford, CA.
Published April 2023. Accessed 13 June 2023. https://
aiindex.stanford.edu/wp-content/uploads/2023/04/
HAI_AI-Index-Report_2023.pdf
6. Food and Drug Administration. Artificial and
Machine Learning (AI/ML)-Enabled Medical
Devices. Last updated 5 October 2022. Accessed
14 June 2023. https://www.fda.gov/medi-
cal-devices/software-medical-device-samd/
artificial-intelligence-and-machine-learning-aiml-en-
abled-medical-devices
7. Reuter E. 5 takeaways from the FDA’s list of
AI-enabled medical devices. MedTech Dive. Published
online 7 November 2022. Accessed 13 June 2023.
https://www.medtechdive.com/news/FDA-AI-ML-
medical-devices-5-takeaways/635908/
8. Alabahri AS, et al. A systematic review of trustworthy
and explainable artificial intelligence in healthcare:
assessment of quality, bias risk, and data fusion. Inf
Fusion. 2023 96:156-191. Verified 13 June 2023.
9. McCarthy J. What Is artificial intelligence? Stanford
University, Stanford, CA. Revised 12 November 2007.
Accessed 25 October 2023. http://jmc.stanford.edu/
articles/whatisai/whatisai.pdf
10. 21 CFR §892.2080. Radiological computer aided triage
and notification software. Current as of 23 October
2023. Accessed 25 October 2023. https://www.ecfr.gov/
current/title-21/chapter-I/subchapter-H/part-892/sub-
part-B/section-892.2080
11. 21 CFR §892.2070. Medical image analyzer. Current as
of 23 October 2023. Accessed 25 October 2023. https://
www.ecfr.gov/current/title-21/chapter-I/subchapter-H/
part-892/subpart-B/section-892.2080
12. Food and Drug Administration. Computer-assisted
detection devices applied to radiology images and
radiology device data -premarket notification [510(k)]
submissions [guidance]. Current as of 28 September
2022. Accessed 13 June 2023. https://www.fda.gov/reg-
ulatory-information/search-fda-guidance-documents/
computer-assisted-detection-devices-applied-radiolo-
gy-images-and-radiology-device-data-premarket
13. Digital Imaging and Communication in Medicine. Last
updated 14 June 2023. Accessed 14 June 2023. https://
www.dicomstandard.org/current
14. Al-Zaiti SS, et al. A clinician’s guide to understanding
and critically appraising machine learning studies: a
checklist for ruling out bias using standard tools in
machine learning (ROBUST-ML). Eur Heart J Digit
Health. 2022 3(2):125–140. Verified 13 June 2023.
15. Food and Drug Administration. The 510(k) pro-
gram: evaluating substantial equivalence in premarket
notifications [510(k)] [guidance]. Current as of 9 June
2023. Accessed on 13 June 2023. https://www.fda.gov/
media/82395/download
16. 21 CFR §814.20(b)(3)(i). Indications for use. Current
as of 9 June 2023. Accessed 13 June 2023. https://www.
ecfr.gov/current/title-21/chapter-I/subchapter-H/part-
814/subpart-B/section-814.20
17. International Medical Device Regulators Forum.
Software as medical devices (SaMD): key definitions.
SaMD WG/N10. Dated 9 December 2013. Accessed
13 June 2023. https://www.imdrf.org/sites/default/files/
docs/imdrf/final/technical/imdrf-tech-131209-samd-
key-definitions-140901.pdf
18. Food and Drug Administration. Software as a
medical device (SaMD). Current as of 4 December
2018. Accessed 5 July 2023. https://www.fda.gov/
medical-devices/digital-health-center-excellence/soft-
ware-medical-device-samd
19. International Organization for Standardization.
Information technology – artificial intelligence – arti-
ficial intelligence concepts and terminology. ISO/IEC
22989:2022(en). Dated July 2022. Accessed 13 June
2023. https://www.iso.org/obp/ui/#home
20. Food and Drug Administration. Marketing submis-
sion recommendations for a predetermined change
control plan for artificial intelligence/machine learning
(AI/ML)-enabled device software functions [draft
guidance]. Issued 3 April 2023. Accessed 13 June 2023.
https://www.fda.gov/media/166704/download
21. International Medical Device Regulators Forum.
Machine learning-enabled medical devices – a subset
of artificial intelligence-enabled medical devices:
Key terms and definitions. IMDRF AIMD WG
(PD1)/N67. Dated 16 September 2021. Accessed
13 June 2023. https://www.imdrf.org/consultations/
machine-learning-enabled-medical-devices-sub-
set-artificial-intelligence-enabled-medical-devic-
es-key-terms-and-definitions
22. Food and Drug Administration. Clinical performance
assessment: considerations for computer-assisted detec-
tion devices Applied to radiology images and radiology
device data in Premarket Notification (510(k))
submissions [guidance]. Current as of 28 September
2022. Accessed 13 June 2023. https://www.fda.gov/
media/77642/download
23. Fujita H. AI‑based computer‑aided diagnosis
(AI‑CAD): the latest review to read first. Radiol Phys
Technol. 2020 13(1):6-19. Verified 13 June 2023.
24. Doi K. Computer-aided diagnosis in medical imaging:
historical review, current status and future potential.
Computer Med Imaging Graph. 2007 31(4-5):198-211.
Verified 13 June 2023.
134 Regulatory Affairs Professionals Society (RAPS)
3. Perrault R, et al. The AI Index 2019 Annual Report.
AI Index Steering Committee, Human-Centered AI
Institute, Stanford University, Stanford, CA. Published
December 2019. Accessed 13 June 2023. https://hai.
stanford.edu/sites/default/files/ai_index_2019_report.
4. Zhang D, et al. The AI Index 2022 Annual Report.
AI Index Steering Committee, Stanford Institute for
Human-Centered AI, Stanford University. Published
March 2022. Accessed 13 June 2023. https://aiindex.
stanford.edu/wp-content/uploads/2022/03/2022-AI-
Index-Report_Master.pdf
5. Maslej N, et al. The AI Index 2023 Annual Report,
AI Index Steering Committee, Institute for Human-
Centered AI, Stanford University, Stanford, CA.
Published April 2023. Accessed 13 June 2023. https://
aiindex.stanford.edu/wp-content/uploads/2023/04/
HAI_AI-Index-Report_2023.pdf
6. Food and Drug Administration. Artificial and
Machine Learning (AI/ML)-Enabled Medical
Devices. Last updated 5 October 2022. Accessed
14 June 2023. https://www.fda.gov/medi-
cal-devices/software-medical-device-samd/
artificial-intelligence-and-machine-learning-aiml-en-
abled-medical-devices
7. Reuter E. 5 takeaways from the FDA’s list of
AI-enabled medical devices. MedTech Dive. Published
online 7 November 2022. Accessed 13 June 2023.
https://www.medtechdive.com/news/FDA-AI-ML-
medical-devices-5-takeaways/635908/
8. Alabahri AS, et al. A systematic review of trustworthy
and explainable artificial intelligence in healthcare:
assessment of quality, bias risk, and data fusion. Inf
Fusion. 2023 96:156-191. Verified 13 June 2023.
9. McCarthy J. What Is artificial intelligence? Stanford
University, Stanford, CA. Revised 12 November 2007.
Accessed 25 October 2023. http://jmc.stanford.edu/
articles/whatisai/whatisai.pdf
10. 21 CFR §892.2080. Radiological computer aided triage
and notification software. Current as of 23 October
2023. Accessed 25 October 2023. https://www.ecfr.gov/
current/title-21/chapter-I/subchapter-H/part-892/sub-
part-B/section-892.2080
11. 21 CFR §892.2070. Medical image analyzer. Current as
of 23 October 2023. Accessed 25 October 2023. https://
www.ecfr.gov/current/title-21/chapter-I/subchapter-H/
part-892/subpart-B/section-892.2080
12. Food and Drug Administration. Computer-assisted
detection devices applied to radiology images and
radiology device data -premarket notification [510(k)]
submissions [guidance]. Current as of 28 September
2022. Accessed 13 June 2023. https://www.fda.gov/reg-
ulatory-information/search-fda-guidance-documents/
computer-assisted-detection-devices-applied-radiolo-
gy-images-and-radiology-device-data-premarket
13. Digital Imaging and Communication in Medicine. Last
updated 14 June 2023. Accessed 14 June 2023. https://
www.dicomstandard.org/current
14. Al-Zaiti SS, et al. A clinician’s guide to understanding
and critically appraising machine learning studies: a
checklist for ruling out bias using standard tools in
machine learning (ROBUST-ML). Eur Heart J Digit
Health. 2022 3(2):125–140. Verified 13 June 2023.
15. Food and Drug Administration. The 510(k) pro-
gram: evaluating substantial equivalence in premarket
notifications [510(k)] [guidance]. Current as of 9 June
2023. Accessed on 13 June 2023. https://www.fda.gov/
media/82395/download
16. 21 CFR §814.20(b)(3)(i). Indications for use. Current
as of 9 June 2023. Accessed 13 June 2023. https://www.
ecfr.gov/current/title-21/chapter-I/subchapter-H/part-
814/subpart-B/section-814.20
17. International Medical Device Regulators Forum.
Software as medical devices (SaMD): key definitions.
SaMD WG/N10. Dated 9 December 2013. Accessed
13 June 2023. https://www.imdrf.org/sites/default/files/
docs/imdrf/final/technical/imdrf-tech-131209-samd-
key-definitions-140901.pdf
18. Food and Drug Administration. Software as a
medical device (SaMD). Current as of 4 December
2018. Accessed 5 July 2023. https://www.fda.gov/
medical-devices/digital-health-center-excellence/soft-
ware-medical-device-samd
19. International Organization for Standardization.
Information technology – artificial intelligence – arti-
ficial intelligence concepts and terminology. ISO/IEC
22989:2022(en). Dated July 2022. Accessed 13 June
2023. https://www.iso.org/obp/ui/#home
20. Food and Drug Administration. Marketing submis-
sion recommendations for a predetermined change
control plan for artificial intelligence/machine learning
(AI/ML)-enabled device software functions [draft
guidance]. Issued 3 April 2023. Accessed 13 June 2023.
https://www.fda.gov/media/166704/download
21. International Medical Device Regulators Forum.
Machine learning-enabled medical devices – a subset
of artificial intelligence-enabled medical devices:
Key terms and definitions. IMDRF AIMD WG
(PD1)/N67. Dated 16 September 2021. Accessed
13 June 2023. https://www.imdrf.org/consultations/
machine-learning-enabled-medical-devices-sub-
set-artificial-intelligence-enabled-medical-devic-
es-key-terms-and-definitions
22. Food and Drug Administration. Clinical performance
assessment: considerations for computer-assisted detec-
tion devices Applied to radiology images and radiology
device data in Premarket Notification (510(k))
submissions [guidance]. Current as of 28 September
2022. Accessed 13 June 2023. https://www.fda.gov/
media/77642/download
23. Fujita H. AI‑based computer‑aided diagnosis
(AI‑CAD): the latest review to read first. Radiol Phys
Technol. 2020 13(1):6-19. Verified 13 June 2023.
24. Doi K. Computer-aided diagnosis in medical imaging:
historical review, current status and future potential.
Computer Med Imaging Graph. 2007 31(4-5):198-211.
Verified 13 June 2023.