Data Management Manufacturing Technology 
FDA Law Blog
NOVEMBER 29, 2023
Guiding Principle 10 focused on monitoring the performance of the models and managing re-training risks. Transparency This guiding principle calls for manufacturers to be transparent with users regarding the device performance before and after the implementation of the change.
FDA Law Blog
MAY 8, 2023
The 2019 discussion paper, “ Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback ,” introduced the PCCP principle as a means to “enable responsible performance enhancements in AI/ML technologies.”
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FDA Law Blog
JANUARY 5, 2023
It is another effort from CDRH’s Digital Health Center of Excellence to provide structure and guidance to participants across the connected device playing field, including both delivery organizations as well as manufacturers. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.
FDA Law Blog
MARCH 6, 2025
Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. FDA notes the use of data collected outside the U.S.
The Process Street
JANUARY 1, 2024
These solutions may incorporate elements of quality management as part of broader regulatory compliance frameworks, particularly in highly regulated industries like pharmaceuticals and healthcare. It offers a wide range of features tailored to meet the needs of various industries, including manufacturing, healthcare, life sciences, and more.
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