Issue: 56 Food and Drug Law Journal 317--338 (2001).
Although it is doubtful that Congress originally intended it to have such significance, the 510(k) process has become the primary path by whic...read more
Issue: 56 Food and Drug Law Journal 227-240 (2001).
Ensuring the reliability of expert witness testimony in cases involving FDA-regulated products presents a court with significant challenges. Jud...read more
Issue: 56 Food and Drug Law Journal 57-76 (2001).
The practice of reprocessing used single-use medical devices has grown significantly over the past 20 years, despite the added risks of compromise...read more
Issue: 56 Food and Drug Law Journal 99-122 (2001).
This article provides an outline of the laws adopted for the marketing of medical devices in the European Union (EU). One objective of the EU me...read more
Issue: 56 Food and Drug Law Journal 77-98 (2001).
Single-use medical devices (SUDs) increasingly have been reprocessed and reused by various entities in an effort to cut costs. This practice has b...read more
Issue: 55 Food and Drug Law Journal 477-490 (2000)
The Washington Legal Foundation case challenged the Food and Drug Administration's policies and practices regarding manufacturer dissemination or...read more
Issue: 55 Food and Drug Law Journal 389-434 (2000)
More and more frequently, product liability and other tort actions against makers of FDA-regulated products allege causes of action implicating ...read more
Issue: 55 Food and Drug Law Journal 185-192 (2000).
This article analyzes important issues facing the Center for Devices and Radiological Health (CDRH). Topics such as premarket review performanc...read more
Issue: 55 Food and Drug Law Journal 245-254 (2000).
Clinical circumstances and good medical practice occasionally require that physicians modify legally marketed devices for patient use. Such mod...read more
This article compares and contrasts medical device regulation in the United States and the European Union (EU). Further, it discusses the ongoing international efforts toward harmonization of natio...read more