US FDA explains clinical study, pre-market requirements for computer-assisted detection devices
This article was originally published in Clinica
Executive Summary
The US Food and Drug Administration has issued updated versions of two related guidelines on computer-assisted detection (CADe) devices applied to radiology images and radiology device data. The guidelines explain how manufacturers should design and conduct clinical performance studies, and submit pre-market notification, or 510(k), applications for these products.
You may also be interested in...
Reclassification Order Spurs FDA To Update Computer-Assisted Detection Devices Guidance
To mesh with a final order reclassifying medical-image analyzers, the US agency has also published a final guidance on computer-assisted detection (CADe) devices that was first finalized more than six years ago.
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.