Newsletter - June 13, 2024
FDA’s Updated Guidance for AI/ML Medical Devices
This week, the FDA announced six initiatives to address various aspects of medical devices based on artificial intelligence (AI) and machine learning (ML). The programs will address major issues that should be discussed with the FDA when developing and using AI/ML technologies in medical devices...Read More
FDA’s New Guidance on GCP Inspections
FDA inspection or audit for Good Clinical Practices (GCP) is an important step for the FDA review of market approval applications. Although GCP audits have been conducted for more than 50 years, there has been little formal guidance from the FDA about the processes involved, leading to several anecdotes...Read More
FDA’s Updated Guidance for AI/ML Medical Devices
This week, the FDA announced six initiatives to address various aspects of medical devices based on artificial intelligence (AI) and machine learning (ML). The programs will address major issues that should be discussed with the FDA when developing and using AI/ML technologies in medical devices...Read More
FDA’s New Guidance on GCP Inspections
FDA inspection or audit for Good Clinical Practices (GCP) is an important step for the FDA review of market approval applications. Although GCP audits have been conducted for more than 50 years, there has been little formal guidance from the FDA about the processes involved, leading to several anecdotes...Read More