News | Artificial Intelligence | January 12, 2021

FDA Releases AI/Machine Learning Action Plan

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  • Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software's learning over time);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

Low-dose #CT #lung #scans are used to #screen for #lung_cancer in high-risk people such as heavy #smokers

Getty Images

News | Lung Imaging | April 16, 2021
April 17, 2021 — A deep learning algorithm accurately predicts the risk of death from...
CDC and FDA Call for Pause on Janssen COVID-19 Vaccine Due to Rare Blood Clots #COVID19 #Janssen
Feature | Coronavirus (COVID-19) | April 15, 2021 | By Dave Fornell
April 15, 2021 — The U.S.
#SiemensHealthineers #Varian #Siemens The transformative combination accelerates the company’s impact on #global #healthcare and establishes a strong partner for #customers and #patients along the entire #cancer care continuum and for many of the most threatening #diseases
News | Radiology Business | April 15, 2021
April 15, 2021 — Siemens Healthineers AG an
A doctor reading #CXR scans using #SenseCare-Chest #DR Pro #diagnostic #software.

A doctor reading CXR scans using SenseCare-Chest DR Pro diagnostic software.

News | Artificial Intelligence | April 14, 2021
April 14, 2021 — SenseTime, a world-leading...
Comparisons of high definition and standard definition infrared imaging for digital histopathology. Image courtesy of the Beckman Institute

Comparisons of high definition and standard definition infrared imaging for digital histopathology. Image courtesy of the Beckman Institute

News | Breast Imaging | April 14, 2021
April 14, 2021 — Detecting and analyzing breast cancer
The U.S. Food and Drug Administration (#FDA) authorized marketing of #Medtronic's #GIGenius, the first device that uses #artificialintelligence (#AI) based on #machinelearning to assist #clinicians in detecting #lesions (such as #polyps or suspected tumors) in the #colon in real time during a c#olonoscopy.

The GI Genius intelligent endoscopy module works in real-time, automatically identifying and marking (with a green box) abnormalities consistent with colorectal polyps, including small flat polyps.

News | Artificial Intelligence | April 12, 2021
A 37-year-old woman developed a new, palpable left supraclavicular lymphadenopathy lump five days after her first dose of the Moderna COVID-19 vaccine in the left arm. On the day of vaccination, the patient was asymptomatic. This is an example of how the vaccine can mimic cancer and swollen lymph nodes. Image used with permission of RSNA.

A 37-year-old woman developed a new, palpable left supraclavicular lymphadenopathy lump five days after her first dose of the Moderna COVID-19 vaccine in the left arm. On the day of vaccination, the patient was asymptomatic. This is an example of how the vaccine can mimic cancer and swollen lymph nodes. Read more about this case study. Image used with permission of RSNA.

Feature | Coronavirus (COVID-19) | April 09, 2021 | By Dave Fornell, Editor
While the mass COVID-19 vaccinat