Chapter 8. Artificial Intelligence-based Software
138 Regulatory Affairs Professionals Society (RAPS)
93. National Institute of Standards and Technology. AI
risk management framework. Accessed 16 June 2023.
https://www.nist.gov/itl/ai-risk-management-frame-
work
94. Food and Drug Administration. Content of
Premarket Submissions for Device Software Functions
[Guidance]. Issued on 14 June 2023. Accessed 15 June
2023. https://www.fda.gov/media/153781/download?
95. National Institute of Standards and Technology.
Biden-Harris Administration announces new NIST
public working group on AI. Published online 22 June
2023. Accessed 7 July 2023. https://www.nist.gov/
news-events/news/2023/06/biden-harris-administra-
tion-announces-new-nist-public-working-group-ai
96. Organization for Economic Co-operation and
Development. Recommendation of the Council on
Artificial Intelligence. Current as of 21 May 2019.
Accessed 16 June 2023. https://legalinstruments.oecd.
org/en/instruments/OECD-LEGAL-0449
97. Food and Drug Administration. Proposed regulatory
framework for modifications to artificial intelligence/
machine learning (AI/ML) based software as a medical
device (SaMD). Published January 2019. Accessed
15 June 2023. https://www.fda.gov/files/medical%20
devices/published/US-FDA-Artificial-Intelligence-
and-Machine-Learning-Discussion-Paper.pdf
Previous Page Next Page