On April 2, 2019, FDA released a discussion paper entitled “Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)” (the “AI Framework”). The AI Framework is the Agency’s first policy document describing a potential regulatory approach for medical devices that use artificial intelligence (“AI”) and machine learning (“ML”). The … Continue Reading
On January 3, 2019, the National Medical Products Administration (“NMPA”) published a draft standalone software appendix of medical device good manufacturing practice (“Draft Standalone Software GMP” or “Draft Appendix”) for public comment (available here). Comments are due on January 30, 2019. China revised its medical device GMP in 2014, which apply to all classes of … Continue Reading
