Medical Device Legal News with Sam Bernstein: Episode 11
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
If you are a device manufacturer, what human factors and usability information should you include in your marketing submission? What if your device has the same user interface as an existing device?...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more
In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more