Medical Device Legal News with Sam Bernstein: Episode 11
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical device (i.e., 510(k)). ...more
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more
Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more