The U.S. Food and Drug Administration released the agency's first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency's oversight of AI/ML-based medical software.

January 12, 2021 — The U.S. Food and Drug Administration released the agency's first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency's oversight of AI/ML-based medical software.

"This action plan outlines the FDA's next steps towards furthering oversight for AI/ML-based SaMD," said Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH). "The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effective software functionality that improves the quality of care that patients receive. To stay current and address patient safety and improve access to these promising technologies, we anticipate that this action plan will continue to evolve over time."

The AI/ML-Based Software as a Medical Device Action Plan outlines five actions that the FDA intends to take, including:

  • Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software's learning over time);
  • Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms;
  • Fostering a patient-centered approach, including device transparency to users;
  • Developing methods to evaluate and improve machine learning algorithms; and
  • Advancing real-world performance monitoring pilots.

The AI/ML Action Plan is a response to stakeholder feedback received from the April 2019 discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.

The FDA welcomes continued feedback in this area and looks forward to engaging with stakeholders on these efforts. The agency will also continue to collaborate across the FDA to build a coordinated approach in areas of common focus related to AI/ML.

For more information: www.fda.gov


Related Content

News | Prostate Cancer

July 9, 2025 — Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer ...

Time July 09, 2025
arrow
News | Computed Tomography (CT)

July 01, 2025 — NANO-X Imaging Ltd. recently announced a clinical and educational collaboration with Keiser University ...

Time July 03, 2025
arrow
News | Magnetic Resonance Imaging (MRI)

July 2, 2025 — Philips has received FDA 510(k) clearance for SmartSpeed Precise[1] MR’s latest deep learning ...

Time July 03, 2025
arrow
News | Ultrasound Imaging

July 1, 2025 — UPDATE: The final paper is now available at: JMIR AI - ChatGPT-4–Driven Liver Ultrasound Radiomics ...

Time July 01, 2025
arrow
News | Ultrasound Imaging

June 26, 2025 — FUJIFILM VisualSonics Inc., a provider of ultra-high frequency ultrasound and photoacoustic imaging ...

Time June 27, 2025
arrow
News | Magnetic Resonance Imaging (MRI)

June 26, 2025 — Siemens Healthineers has received Food and Drug Administration clearance for the Magnetom Flow.Ace, its ...

Time June 26, 2025
arrow
News | Prostate Cancer

June 26, 2025 – Quibim, a global provider of quantitative medical imaging solutions, has launched AI-QUAL, a new feature ...

Time June 26, 2025
arrow
News | Bone Densitometry Systems

June 19, 2025 — Naitive Technologies has published results demonstrating the diagnostic performance of its AI-powered ...

Time June 18, 2025
arrow
News | Lung Imaging

June 18, 2025 — Exo recently announced that now included on its Exo Iris is the first ever FDA 510(k) cleared AI for ...

Time June 18, 2025
arrow
News | Imaging Software Development

June 12, 2025 — GE HealthCare has announced the combination of GE HealthCare’s proprietary features and algorithms with ...

Time June 12, 2025
arrow
Subscribe Now