The US agency has awarded $2.8m to the Medical Device Innovation Consortium (MDIC) to develop a variant maturity model program for noncompliant device-makers, launch a "boot camp" on cybersecurity threat modeling for devices, and study advanced manufacturing practices used in other industries.
The US Food and Drug Administration has awarded $2.8m to the Medical Device Innovation Consortium (MDIC) to develop a variant maturity model program for noncompliant device-makers, and for other activities.
Medtech Insight reported last month on the FDA's interest in developing a modified version of its popular Case for Quality Voluntary Improvement Program (CFQ VIP) for manufacturers with poor compliance histories
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.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.
In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.
