Makers of software that passively stores, transfers, formats or displays medical device data no longer need to worry about the quality system regulation or other basic device requirements for the products, according to a June 20 draft guidance.
Three years after establishing a class 1 regulatory policy for software that passively stores, transfers, formats or displays medical device data, FDA says enough is enough.
So-called medical device data systems (MDDS) are already exempt from pre-market review. But software makers will now no longer even need to worry about the quality system regulation or other basic device requirements for the products, according to an FDA
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.
