FDA Releases Artificial Intelligence / Machine Learning Action Plan

FDAToday, 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  • Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time);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.

Launched in September of 2020, the CDRH Digital Health Center of Excellence is committed to strategically advancing science and evidence for digital health technologies within the framework of the FDA's regulatory and oversight role. The goal of the Center is to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

About the U.S. Food and Drug Administration (FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Digital ECGs at Barts Health: A High-Imp…

Opinion Article by Dr Krishnaraj Sinhji Rathod, consultant in interventional cardiology, Barts Health NHS Trust. Picture the moment. A patient in an ambulance, enroute to hospital with new chest pain. Paramedics...

Study Sheds Light on Hurdles Faced in Tr…

Implementing artificial intelligence (AI) into NHS hospitals is far harder than initially anticipated, with complications around governance, contracts, data collection, harmonisation with old IT systems, finding the right AI tools...

Using Deep Learning for Precision Cancer…

Altuna Akalin and his team at the Max Delbrück Center have developed a new tool to more precisely guide cancer treatment. Described in a paper published in Nature Communications, the...

New AI Approach Paves Way for Smarter T-…

Researchers have harnessed the power of artificial intelligence (AI) to tackle one of the most complex challenges in immunology: predicting how T cells recognize and respond to specific peptide antigens...

Study Used AI Models to Improve Predicti…

Chronic kidney disease (CKD) is a complex condition marked by a gradual decline in kidney function, which can ultimately progress to end-stage renal disease (ESRD). Globally, the prevalence of the...

AI-Powered CRISPR could Lead to Faster G…

Stanford Medicine researchers have developed an artificial intelligence (AI) tool to help scientists better plan gene-editing experiments. The technology, CRISPR-GPT, acts as a gene-editing “copilot” supported by AI to help...

Groundbreaking AI Aims to Speed Lifesavi…

To solve a problem, we have to see it clearly. Whether it’s an infection by a novel virus or memory-stealing plaques forming in the brains of Alzheimer’s patients, visualizing disease processes...

AI Spots Hidden Signs of Depression in S…

Depression is one of the most common mental health challenges, but its early signs are often overlooked. It is often linked to reduced facial expressivity. However, whether mild depression or...