Open Access. Powered by Scholars. Published by Universities.®
- Discipline
- Institution
Articles 1 - 3 of 3
Full-Text Articles in Law
Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann
Reprocessing Single-Use Medical Devices: The State Of The Debate, Brian E. Ray, Mark Hermann
Law Faculty Articles and Essays
Reprocessing single-use medical devices is a growing but controversial industry subject to an increasingly complex and fast-developing set of regulations and a wide range of unresolved legal issues.
“After You, My Dear Alphonse!”: Should The Courts Defer To The Fda’S New Interpretation Of § 360k(A) Of The Medical Device Amendments?, Richard C. Ausness
“After You, My Dear Alphonse!”: Should The Courts Defer To The Fda’S New Interpretation Of § 360k(A) Of The Medical Device Amendments?, Richard C. Ausness
Law Faculty Scholarly Articles
Under the provisions of the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act certain medical devices are subject to premarket approval of the Food and Drug Administration (FDA). Section 360k(a) of the MDA provides that states may not establish “any requirement” which relates to safety or effectiveness of a medical device and "which is different from, or in addition to" any requirement imposed by the FDA. Until recently, the FDA maintained that § 360k(a) did not preempt most common law tort claims; however, in recent amici briefs, the FDA has aggressively asserted that most, if not all, …
The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn
The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn
Faculty Journal Articles and Book Chapters
The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.
Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …