The US agency has authorized the first COVID-19 test to use at-home saliva sample collection. Rutgers Clinical Genomics Laboratory landed the emergency use authorization.
The first test that allows people to collect saliva samples at home for diagnosis of COVID-19 won authorization from the US Food and Drug Administration on 8 May.
Rutgers Clinical Genomics Laboratory landed the emergency use authorization (EUA) for its COVID-19 lab-developed test, which is an add-on to...
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?
