The US FDA is now allowing users to submit 510(k), PMA, and other premarket applications through its Customer Collaborations Portal, which previously only allowed users to track submissions.
The Food and Drug Administration’s Customer Collaborations Portal (CCP), an online platform for tracking traditional 510(k) submissions to the agency, has now been updated to allow users to submit applications.
Prior to the update, the CCP could only be used to track traditional 510(k) submissions that had been physically shipped to the FDA.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
