The deadline is 24 May to comment on one of the biggest regulatory changes in the history of the US FDA’s device center.
As of 12 May, 34 stakeholders have commented via Regulations.gov on the US Food and Drug Administration’s draft Quality Management System Regulation (QMSR). Of those, 32 have been made public.
There are only a dozen days left for industry and others to make their voices heard in the shaping of the agency’s replacement for its
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.
