The US agency issued a revised version of an Emergency Use Authorization (EUA) to the Centers for Disease Control and Prevention for the CDC’s COVID-19 test on 15 March, and approved an amendment to New York State’s EUA for its assay on the same day.
A revised version of the US Centers for Disease Control and Prevention’s coronavirus diagnostic was reauthorized by the Food and Drug Administration on 15 March, FDA commissioner Stephen Hahn announced in a 16 March series of tweets.
The CDC’s test, known as the CDC 2019-Novel Coronavirus Real-Time Reverse Transcriptase RT-PCR Diagnostic Panel, was initially authorized by the...
16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.
The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.
16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
