Day: December 5, 2024

Medical devices containing Artificial intelligence (AI) and Machine Learning (ML) technologies inherently require updates as the software self-trains on the data generated internally, improving their performance over time which, in turn, triggers the threshold of a new 510k or a PMA amendment creating regulatory burden for the manufacturer. A new FDA guidance document provides a … Read more

The U.S. Food and Drug Administration (FDA) recently released two reports outlining its strategies for improving communication with stakeholders and developing guidance documents. The report on communications lists seven ways the FDA communicates with stakeholders, while the report on guidance documents describes the process to create new or update guidance documents, standardized format, and review … Read more