Medical Device Legal News with Sam Bernstein: Episode 11
When Congress passes sweeping retirement legislation, the details often come later—and those details usually come in the form of regulatory spaghetti that plan sponsors and administrators are left to untangle. Case in point:...more
On 18 July 2025, the European Commission (EC) published the draft guidelines on the implementation of the Foreign Subsidies Regulation (FSR Guidelines)....more
On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” offering an expanded framework...more
Regulation of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) in soils under New York’s remedial programs was a little erratic in 2024. As to their inclusion in the New York State Department of...more
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more