The FDA expects that outside reviewers will be able to handle about half of all lab-developed test submissions, a spokesman told Medtech Insight. Meanwhile, a recent CDRH memo discussing COVID-19 test validation offers further background on why the agency is concerned about LDT accuracy and reliability.
The US Food and Drug Administration is responding to the storm of commentary around its proposed rule on lab-developed tests with additional explanations, a memo from device-center official Elizabeth Hillebrenner, and plans for a webinar at the end of this month.
The proposed rule, which was issued on 29 September, lays out the agency’s planned approach to regulating LDTs as it does other diagnostics. It could be fully implemented as soon...
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.
