FDA GREEN LIGHT$$$$$$$
US Patent 11817214 is not titled "Machine learning model fda approval." Instead, the US Food and Drug Administration (FDA) has published several documents and guidance documents regarding the approval of AI/ML-based medical devices, including a list of cleared or approved AI/ML devices. The FDA has developed a framework and action plan to address the unique challenges of continuously learning AI/ML devices, ensuring they are safe and effective while allowing for iterative updates.
FDA guidance on AI/ML device approval
Action Plan: The FDA released its "Artificial Intelligence and Machine Learning Software as a Medical Device (AI/ML SaMD) Action Plan" to address the unique characteristics of these devices.
Premarket Review: For AI/ML-based medical devices, a premarket submission may be required for modifications that significantly affect the device's performance, safety, or effectiveness, or for changes to the intended use.
Predetermined Change Control Plan: The FDA's draft guidance recommends that manufacturers include a "Predetermined Change Control Plan" (PCCP) with their initial marketing submission. This plan outlines how the manufacturer intends to manage and update the AI/ML software function over time while maintaining safety and effectiveness.
Guiding Principles: The FDA has issued guiding principles for good machine learning practice for medical device development and for implementing predetermined change control plans.
FDA-approved AI/ML devices
Increasing Approvals: The number of FDA-authorized AI/ML-based medical devices has grown significantly, particularly in recent years.
Transparency: The FDA has also published a searchable list of legally marketed devices that incorporate AI/ML to improve transparency for stakeholders.
Device Characteristics: The FDA provides basic information for each device on the list, including the decision date, manufacturer, and the lead medical specialty review panel.
Market Data 
Markets 
AI
