FDA Releases Artificial Intelligence/Machine Learning Action Plan (FDA press release):
Today, 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 … 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- Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time);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.
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.
The Action Plan:
- Title: Artificial Intelligence and Machine Learning in Software as a Medical Device
- Description: The U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence. The Action Plan is a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device” and outlines five actions the FDA intends to take.
- To Learn More and Download: click HERE
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- June: FDA clears first videogame to be prescribed to kids with ADHD: EndeavorRx by Akili Interactive Labs
- May: Portable brain assessment device by Headsafe secures 510(k) FDA clearance
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