AI, including machine learning (ML), spans transformative technologies with the potential to revolutionize healthcare

March 15, 2024 — Today, the U.S. Food and Drug Administration (FDA) released its “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines how FDA’s medical product centers are working together to protect public health while fostering responsible innovation in artificial intelligence (AI) used in medical products and their development.

AI, including machine learning (ML), spans transformative technologies with the potential to revolutionize healthcare. The paper reaffirms our commitment to promote health equity by promoting the secure, safe, ethical, and effective development, deployment, and use of AI in medical products.

The complex and dynamic processes involved in the development, deployment, use, and maintenance of AI technologies benefit from careful management throughout the medical product life cycle. This paper describes our shared commitment and outlines four priorities for cross-center collaboration to foster consistency across the FDA.

Published by the FDA’s Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP), this paper represents our longstanding commitment to protect public health and advance innovation.

The Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” is meant to complement the "Artificial Intelligence and Machine Learning Software as Medical Device Action Plan," published in January 2021.

You can read the full paper here.

 


Related Content

News | Lung Imaging

April 17, 2024 — A Medicare policy requiring primary care providers (PCPs) to share in the decision-making with patients ...

Time April 17, 2024
arrow
News | Radiology Business

April 17, 2024 — VISTA.AI announced the appointment of Daniel Hawkins as President and CEO. The company is pioneering AI ...

Time April 17, 2024
arrow
News | Magnetic Resonance Imaging (MRI)

April 17, 2024 — Hyperfine, Inc., a groundbreaking health technology company that has redefined brain imaging with the ...

Time April 17, 2024
arrow
News | Mammography

April 16, 2024 — The Radiological Society of North America (RSNA) and GE HealthCare announced their collaboration to ...

Time April 16, 2024
arrow
Videos | Breast Imaging

Don't miss ITN's latest "One on One" video interview with AAWR Past President and American College of Radiology (ACR) ...

Time April 15, 2024
arrow
News | ACR

April 15, 2023 — The American College of Radiology (ACR) released an update to its ACR Appropriateness Criteria (ACR AC) ...

Time April 13, 2024
arrow
News | Mammography

April 12, 2024 — GE HealthCare, a leader in breast health technology and diagnostics, will feature its latest breast ...

Time April 12, 2024
arrow
News | Society of Breast Imaging (SBI)

April 11, 2024 — iCAD, Inc., a global leader in clinically proven AI-powered cancer detection solutions, announced today ...

Time April 11, 2024
arrow
News | Cybersecurity

April 10, 2024 — The American Medical Association (AMA) released informal survey findings (PDF) showing the ongoing ...

Time April 10, 2024
arrow
News | Magnetic Resonance Imaging (MRI)

April 10, 2024 — Online MRI and CT education leader, ImagingU, announced the launch of a new course for students and ...

Time April 10, 2024
arrow
Subscribe Now