[FEATURED] EU Proposal To Have Guidance Transition Periods “Does Not Make Sense”
A proposed position paper on time periods for notified bodies to roll out guidance documents aims to introduce greater predictability. But has the EU notified body organization gone too far […]
[FEATURED] FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices
In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software […]
[FEATURED] FDA-Backed Tumor Mutation Database Gives Diagnostics Developers Another Premarket Submission Tool
The US FDA on 7 October recognized a portion of the Oncology Knowledge Base, or OncoKB, which test makers can use as they work to complete premarket submissions. It’s the […]
