Medical Device Legal News with Sam Bernstein: Episode 11
FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
In February 2018, the U.S. Army Corps of Engineers (“Corps”) issued a draft Engineering Circular (“EC”) outlining proposed policies and procedures regarding how it will address third-party requests to alter civil works...more
Happy New Year!!!!!! Yes, it is actually February, but it is a new year for this blog as we turn our attention to a world full of flood risk reduction actions in the second year of the Trump Administration. We are hearing...more