In a long-awaited final guidance, FDA affirmed its plan to practice enforcement discretion for most mobile medical apps, except those applications that present the same risks as conventional FDA-regulated devices. Some digital health stakeholders praised the guidance, while others wished FDA has waited.
FDA will actively regulate only the small portion of mobile medical applications that present the same risks as conventional FDA-regulated devices, the agency affirmed in the much-anticipated mobile apps final guidance issued Sept. 23.
Sticking to a policy outlined in its 2011 draft guidance, the agency will apply enforcement discretion to a long list of lower-risk app types, even if they might technically meet...
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.
