The US department that oversees the FDA says the agency acted beyond its authority in asking labs to file emergency use authorizations, asserting that only CLIA rules should apply.
Creators of laboratory developed tests (LDTs) for COVID-19 don’t need to notify the US Food and Drug Administration before taking the diagnostics to market, the Department of Health and Human Services (HHS) said in a 19 August announcement.
The statement says the FDA won’t impose premarket review on LDTs absent the formal notice-and-comment rulemaking process. The requirement can’t be set via guidance documents, website statements, compliance manuals and...
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.
