US FDA identifies cybersecurity risks in certain patient monitors
The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with certain patient monitors from Contec and Epsimed and urged healthcare ...
JD Supra11h
International AI Regulatory Contrast: Evolving frameworks in the EU, UK, and US
In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...
Healio19h
Decentralized clinical trials: FDA guidance and the ‘new modus operandi’
The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...
GlobalData on MSN19h
FDA protocol deviation guidance could go further
The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.