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Luann M. Pendy usually is the consummate guest in her customers' corporate castles. During her visits, the Medtronic Inc. quality executive abides by the rules of basic business etiquette: She's [...]

TABLE OF CONTENTS I. INTRODUCTION II. FDA's Medical DEVICE REGULATORY FRAMEWORK A. The Medical Device Amendments of 1976 B. Three Classes, Three Types of Oversight. C. The 510(k) Scheme 1. [...]

IF you have prosecuted even a handful of products liability cases, you have likely come across a defendant that has a foreign parent or foreign-associated entity. Many pharmaceutical and medical [...]

As the Centers for Medicare & Medicaid Services (CMS) of the U.S. Department of Health and Human Services (HHS) prepares to finalize its proposed rule (1) implementing the Sunshine Act, [...]

For medical devices, good engineering does not guarantee clinical trial or commercial success. The climate for introducing new medical devices into the market has become increasingly difficult in recent years. [...]

In an August 25, 2011 decision, the U.S. Court of Appeals for the Third Circuit ruled that a district court did not abuse its discretion in denying property owners' motion [...]

FOR MANUFACTUERS of prescription drugs and medical devices, preventing the "off-label" promotion of their products (i.e., marketing the product for uses for which it was not approved) has always been [...]

As clinical research and manufacturing expand globally, pharmaceutical and medical device companies face increased risk of noncompliance with the US Foreign Corrupt Practices Act (FCPA), an anti-bribery law enacted in [...]

INTRODUCTION What can you do if you learn you have a life-threatening illness but there is no Food and Drug Administration-approved medicine to treat it? Sometimes, there is nothing to [...]

On August 27, 2010, the Centers for Medicare & Medicaid Services (CMS) issued a final rule outlining a new regulation enhancing Medicare enrollment standards for suppliers of durable medical equipment, [...]

'Global Regulatory Viewpoint' addresses various regulatory and compliance topics including newly published regulations. This column discusses regulatory information from a global perspective. The content in this column is useful to [...]

'Engineering for Non-Engineers' discusses science and engineering principles associated with equipment, utilities, facilities, and associated GMP systems useful to practitioners in compliance and validation. We intend this column to be [...]

The ability to sue manufacturers of pharmaceutical drugs and medical devices is being challenged by an unlikely source: the Food and Drug Administration (FDA). Until recently, most courts allowed injured [...]

This article provides a life-cycle methodology in a multi-phase approach that includes an effective design control process. Emphasis is put on the practices employed to control the various design and [...]

Between the reporting requirements of the Federal Food, Drug and Cosmetic Act (FDCA) and potential products liability exposure, drug and medical device manufacturers have very little room for error. Because [...]

Joy Gordon Product Manager SolidWorks Corp. Concord, Mass. Companies developing medical devices--whether for diagnostics, prosthetics, monitoring, or surgery and treatment--face tough challenges that most other manufacturers are blissfully unaware of. [...]

INTRODUCTION Not all medical devices require clinical investigation in order to demonstrate their safety and efficacy. But, even for some class II medical devices that can be cleared by the [...]

It is well known that a newly developed medical device must ordinarily undergo a pre-market approval process before it can be used on the general patient population by rank-and-file physicians. [...]