Makers of automated external defibrillators are vigorously opposed to FDA’s proposal to require PMAs for the devices. A petition submitted by Philips Healthcare asks the agency to reclassify the devices into class II with special controls.
Industry is fighting FDA’s proposed order to require PMAs for automated external defibrillators, saying the devices’ safety and effectiveness have been demonstrated and the 501(k) route with class II special controls is appropriate.
FDA’s March proposal, if finalized, would require AED manufacturers to submit PMAs for the devices. Since the devices were on the market prior to passage of the 1976 Food, Drug...
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.
