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  1. Artificial Intelligence and Medical Products

Artificial Intelligence at FDA: Publications

AI has the potential to revolutionize health care by advancing medical product development, improving patient care, and augmenting the capabilities of health care practitioners.

See the below table for AI related discussion papers, reports, and constituent updates from the Agency.


More Publications on Artificial Intelligence

Date Title Document Type
May 2023 Using Artificial Intelligence & Machine Learning in the Development of Drug and Biological Products Discussion Paper
April 2023 Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions: Draft Guidance for Industry and Food and Drug Administration Staff Guidance Document
March 2023 FDA Releases FDA Activities for the Safety of Imported Seafood Constituent Update
February 2023 Artificial Intelligence in Drug Manufacturing Discussion Paper
August 2022 The FDA Moves into Third Phase of Artificial Intelligence Imported Seafood Pilot Program Constituent Update
April 2019 Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) - Discussion Paper and Request for Feedback Discussion Paper
October 2022 Distributed Manufacturing and Point of Care Manufacturing of Drugs Discussion Paper
August 2022 The FDA Moves into Third Phase of Artificial Intelligence Imported Seafood Pilot Program Constituent Update
September 2022 Focus Area: Artificial Intelligence Report
February 2021 FDA Moves into Second Phase of AI Imported Seafood Pilot Program Constituent Update
January 2021 Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan Action Plan
November 2019 FDA Extends Comment Period on the New Era of Smarter Food Safety Constituent Update
September 2019 FDA Announces Public Meeting to Discuss the New Era of Smarter Food Safety Constituent Update

 

 
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