Our most popular stories last month included an exclusive item on FDA's next steps for its device Case-for-Quality program; a graphical analysis of the agency's MDUFA III performance, three years into the program; a guest column from a former CDRH Office of Compliance director; and more.
Although positive feedback came out of a Center for Devices and Radiological Health test-run of an inspection approach targeting design and manufacturing elements deemed "critical" to the quality of implantable devices with batteries, the center decided not to move forward with the specialized inspection practice on a broader basis, but rather issue guidance documents on "critical-to-quality" topics.
That was the news from the most popular story on TheGraySheet.com
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.
