The decision limits US FDA discretion in determining how to regulate products that seem to meet both drug and device standards.
A contrast agent used during radiology scans is legally a device and not a drug, the DC Circuit Court of Appeals determined on 16 April in a rebuke to the US Food and Drug Administration.
The ruling marked a victory for Genus Medical Technologies, who sued the FDA in 2019 after the agency determined that its barium sulfate products, which are sold under the brand name Vanilla SilQ, should be regulated as drugs
The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.
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.
