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Breakthrough at FDA

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published January 1996 James G. Dickinson T hrough its grassroots regulatory partnership meetings held around the country, FDA seems to have successfully broken loose from the policy noose that is the...

Burlington Answers WLF

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published January 1996 Examples of industry-funded harassment of FDA can be found in the publications of the Washington Legal Foundation (WLF; Washington, DC). WLF issues periodic statements attacking the...

FDA Withdraws Laerdal Warning Letter

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published January, 1996 Do you remember FDA ever officially withdrawing a warning letter or its equivalent? Medical device attorney Larry Pilot of the law firm McKenna & Cuneo (Washington, DC), says he...

Grace Period for IVD Makers

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published January, 1996 CDRH's new compliance policy guide (CPG) for in vitro diagnostic (IVD) devices will provide a 30-month grace period for all manufacturers to collect data and submit them to FDA for...

STRATEGIES

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published January 1996 David Casal In recent years, the process of receiving approval from FDA to distribute a medical device commercially has become increasingly long and perilous. Review times for...

Merger Mania Strikes Device Industry

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published January 1996 Greg Freiherr Rapid consolidation of medical device companies is changing not only the number of industry players, but also the roles they will play in the future. In the past 12...

Asia's Aging Population Creates Opportunities for U.S. Firms

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published January, 1996 Ames D. Gross Rapid economic growth is changing health care throughout Asia, and creating new opportunities for medical device suppliers in the process. As Asian countries become more...

India Presents R&D Opportunities for U.S. Device Companies

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published January 1996 Pratap Khanwilkar

Tech Transfer Moves Defense Innovations to Device Manufacturers

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published January 1996 Robert S. Seeley U.S. medical device manufacturers in search of new technologies occasionally need look no further than their own government. Some of these firms can participate in ...

Clinical Trials: An Introduction

Kshitij Mohan and Harold E. Sargent Throughout most of human history, the advance of medical practice has depended largely on accidental discoveries and observational data. Often, treatments or therapies with unmistakably positive effects on patients have been discovered by chance and subsequently...

Continuation of MDDI's January 1996 article, "Clinical Trials: An Introduction"

Back to previous page Medical devices vary greatly with respect to their type, their population for intended use, and the significance of risk posed by their use. FDA's device regulations recognize these differences by classifying devices into three categories--Class I, II, and III--with Class III...

Continuation of MDDI's January 1996 article, "Clinical Trials: An Introduction"

Back to front page of story Over the past few years, there has been much controversy and upheaval in the regulation of medical devices in the United States and, to a lesser extent, in Europe. The result has been a variety of emerging structural and directional changes in the clinical trial arena...

Revolution by Phases: FDA's Regulation of Investigational Device Exemptions

Medical Device & Diagnostic Industry Magazine MDDI Article Index Jonathan S. Kahan The collection and evaluation of clinical data to demonstrate the safety and efficacy of a medical device are absolutely essential for the ultimate premarket approval of all Class III devices. Under...

<B>Continuation of MDDI's January 1996 article, "Revolution by Phases: FDA's regulation of Investigational Device Exemptions"</B>

Back to previous page Although it is probably belaboring the obvious, the design and conduct of the clinical trial are the keys to ultimate marketing approval of the device. The data generated by the clinical trial must support the claims that the sponsor intends to make for the marketed device and...