Medical Device Legal News with Sam Bernstein: Episode 11
On November 21, 2024, the U.S. EPA released a new draft framework – the Interim Framework for Advancing Consideration of Cumulative Impacts – intended to provide EPA’s employees with guidance for how they should consider...more
On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more
The Information Commissioner’s Office (ICO), the personal data protection authority in the United Kingdom (UK), is running a public consultation on its draft guidance on biometric data which covers the requirements under the...more