The agency issued a final guidance spelling out reasonable applications of real-world device evidence and what factors must be considered when weighing whether data collected from routine care via means – such as electronic patient records or insurance claims – can help support a product approval or other regulatory decision.
Real-world device data may be suitable to support clearance or approval of a new device or expanded indication, but controls to mitigate bias and ensure data is sufficiently relevant and reliable are a must, US FDA conveys in a final guidance posted Aug. 30.
The final "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices" tracks very closely to a draft version issued in July 2016, but it includes some...
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.
Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.
HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
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.
