American Hospital Association

FDA issues guidance on wellness products, clinical decision support software

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
MD&M East

Software Version Control for Medical Devices: Turning Traceability into Compliance Confidence

In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...
MobiHealthNews

FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...
JD Supra

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...