On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological...more
Researchers from the University of Washington have developed a system that uses smart speakers and machine learning algorithms to monitor heartbeats without the need for physical contact. The system was described in a study...more
FDA Announces Intent to Modernize the Medical Device Review Process that Would Discourage Reliance on Older Devices as Predicates for the 510(k) Process - Last week FDA released two statements announcing plans and...more
Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more
Recognizing both the opportunities and the potential regulatory challenges presented by such rapid development, the FDA – under the leadership of recently confirmed Commissioner Dr. Scott Gottlieb – is spearheading a new...more
Based on recent FDA statements, it looks as though the FDA would like to integrate hospital medical device reporting obligations into the National Evaluation System for health Technology (NEST) framework. The NEST system is a...more
The FDA‘s planned National Evaluation System for Health Technology (NEST) will focus on new forms of clinical data, data sharing, and advanced analytics as the keys to optimizing the medical device ecosystem, says a new...more