Medmarc Blog (blog.medmarc.com)
Medical Device Regulation (MDR)
AI Regulation Lagging Behind Innovation and Creating Friction
Developers of artificial intelligence (AI) products have moved quickly into a wide range of product types, but regulatory agencies are struggling to keep pace. One of the issues for industry is that...
FDA Appoints New Director for Center for Devices
The FDA has appointed a new director for the Center for Devices and Radiological Health (CDRH) to replace Jeff Shuren, who has been at the helm of CDRH since 2009. Michelle Tarver has taken over as...
FDA Final Rule for LDTs Offers Four-Year Phase-In
The FDA’s final rule for laboratory-developed tests (LDTs) imposes a large compliance burden on clinical laboratory operations, a fact which has sparked renewed interest in legislation. However, the...
Backlog of EU Device Applications Continues to Grow
The European Union’s ongoing struggles with the implementation of the Medical Device Regulation (MDR) are well known, although there are ways to make some of the associated workload more...
Medicare Rule for Breakthrough Devices Returns
The Centers for Medicare and Medicaid Services has resubmitted the rule for Medicare coverage of FDA breakthrough devices with a modified plan for the application and for the process of...
WHO Urges Nations to Adopt National Strategies for Diagnostics
In the wake of the COVID-19 pandemic, the World Health Organization has adopted a resolution that has received the backing of MedTech Europe and the Advanced Medical Technology Association...
FDA Seeks Feedback on AI in Drug Development, Manufacturing
The FDA is working to adapt its regulatory regimes to the use of artificial intelligence (AI) across the agency’s product centers, a response to the frequent use of AI for a variety of regulated...
New Extension Proposed for European Union’s Medical Device Regulation
Timelines for compliance with the European Union’s Medical Device Regulation (MDR) may be extended again via a legislative proposal recently released by the European Commission (EC), which would...