Medical Device & Diagnostic Industry

June 1996 MD&DI
Selected Contents

Regulatory Affairs

Hurdles to Harmonization: FDA Struggles to Balance Priorities
Sherrie Steward

Inside the walls of the beleaguered FDA, officials are struggling to communicate to manufacturers the dynamics of FDA's structure, its priorities, and its role in both establishing and endorsing international standards. Shrinking resources have forced the agency to adopt a rigid stance in determining its priorities, complicating its participation in the harmonization process.

Regulatory Affairs

Reform Bills Set for Showdown

Advocates and opponents of comprehensive FDA reform are focusing their attention on four bills developed in recent months by congressional committees with jurisdiction over FDA—the Senate Labor and Human Resources Committee and the House Commerce Committee.

Business & Marketing

Information Technologies Top Hospital Purchasing Priorities
Daphne Allen

According to two recent surveys, hospital financial managers are increasing their investments in information technologies. Many are purchasing nonmedical equipment such as data processing and telecommunications technologies at a higher rate than they are diagnostic and therapeutic equipment.

FDA

Legislating a New and Improved FDA
James C. Greenwood

Two months ago, more than 300 individuals and patient groups signed an "open letter" to Congress. They made an astounding statement, one that was powerful in its simplicity: FDA delays are killing people.

Business & Marketing

Industry Can Benefit from Quality in Managed-Care Plans
Paul M. Ellwood

The healthcare community is on the verge of an information revolution, one that will allow managed care to achieve the goal that its inventor, Paul M. Ellwood, Jr., first had in mind some 25 years ago.

Washington Wrap-up

Rebuilding Device Regulation
James G. Dickinson

Two major developments in March signaled an overall rebuilding of the way this country regulates medical devices.

Business & Marketing

Long-Range Planning Sets the Foundation for Efficient Expansion
Greg Freiherr

The rapid growth of young, successful medical device companies can mean frequent site changes in the search for adequate space. With long-range planning, some companies have been able to minimize these costly, frustrating moves.

Software

Advancing Technologies Put Device Software on the Fast Track
Steven Halasey

In the past decade, the medical device industry has witnessed a proliferation of software-controlled products, including everything from handheld diagnostics to radiological treatment devices. Yet the inner workings of these products have remained, for most, a grand mystery.

Regulatory Affairs

Biostatistics and the Analysis of Clinical Data
Richard P. Chiacchierini

Analysis of the data from a medical device clinical trial or study is one of many critical steps along the path to FDA approval and, ultimately, to the marketplace.

Materials

Manufacturer Use of ODE's Blue Book Memorandum on Biocompatibility Testing
Brenda Seidman

Last July, the Office of Device Evaluation at CDRH officially replaced its longstanding use of the 1987 "Tripartite Biocompatibility Guidance for Medical Devices" with a new policy designed to bring the agency's requirements into accord with newer international standards for evaluating the biocompatibility of medical devices.

Sterilization

ISO Standard Redefines Limits for EtO Residuals
Barry Page

The ISO standard for EtO sterilization residuals sets new limits using a different basis than that used by FDA in its 1978 proposal.