Medical Device Legal News with Sam Bernstein: Episode 11
In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a regulatory framework that allows medical device manufacturers to implement certain pre-approved...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more
Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more