Day: October 6, 2022

For developers of medical devices using artificial intelligence (AI) and/or machine learning (ML) tools, precedent information is critical. Being a new field, there are few public resources to plan and strategize development steps for FDA approval. FDA’s list of AI/ML-enabled medical devices is hence a priceless gift to the developers. FDA has been maintaining this … Read more

This week the US Congress unanimously cleared the Bill S.5002 which requires FDA to allow alternatives to animal testing for drug and biological applications. While there is a strong bi-partisan political support in the US for this bill, in practicality it may have minimal impact on the animal tests required by FDA. Animal testing is … Read more