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Joint Notice: Guiding Principles for ML Devices
The article describes the approach to be applied to innovative medical devices utilizing machine-learning technology.
The article describes the approach to be applied to innovative medical devices utilizing machine-learning technology.
The new article outlines the key considerations based on the class of the medical devices in question under the applicable risk-based classification system.
The article provides a general overview of the approach to be followed when applying for a medical device license necessary to place a new product on the market.
The new article provides a general overview of the essential information to be included in the medical device application to ensure its completeness.
The new article highlights certain specific matters to be addressed in all the applications for a medical device license in order to ensure the authority is provided with all the information needed to assess the safety and effectiveness of the product subject to review.
The new article describes in detail the authority’s review process when assessing applications related to medical devices.