medical-devices | journals | Knowledge Center

The Evolution of Substantial Equivalence in FDA's Premarket Review of Medical Devices

Posted on August 2001 by Benjamin A. Goldberger

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

Clearing Away the Junk: Court-Appointed Experts, Scientifically Marginal Evidence, and the Silicone Gel Breast Implant Litigation

Posted on May 2001 by Peter J. Goss, Debra L. Worthington, Merrie Jo Stallard, & Joseph M. Price

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

Going 90 in a 55 M.P.H. Speed Zone: Reprocessing of Used Single-Use Medical Devices and the Food and Drug Administration's Non-Enforcement of the Food, Drug, and Cosmetic Act

Posted on March 2001 by Kurt R. Karst

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

An Assessment of the Regulations on Medical Devices in the European Union

Posted on March 2001 by Sharon Frank

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

Regulatory and Legal Implications of Reprocessing and Reuse of Single-Use Medical Devices

Posted on March 2001 by Emil P. Wang

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

The WLF Case Thus Far: Not With a Bang, But a Whimper

Posted on November 2000 by Richard M. Cooper

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

Challenging the Viability of FDCA-Based Causes of Action in the Tort Context: The Orthopedic Bone Screw Experience

Posted on August 2000 by James M. Beck & John A. Valentine

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

Update on the Center for Devices and Radiological Health

Posted on May 2000 by Elizabeth D. Jacobson

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

Physician Modification of Legally Marketed Medical Devices: Regulatory Implications Under the Federal Food, Drug, and Cosmetic Act

Posted on May 2000 by John J. Smith

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

Medical Device Regulation in the United States and the European Union: A Comparative Study

Posted on March 2000 by John Y. Chai

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

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