Medical Device & Diagnostic Industry

July 1996 MD&DI
Selected Contents

Regulatory Affairs

Helpful Design Guidance, or Stealth Regulation?
John Bethune

Last March, FDA released two important draft guidances on design, entitled "Design Control Guidance for Medical Device Manufacturers" and "Do It by Design." These are both important documents that everyone involved in device design should read, in part because they clarify FDA's expectations, but more significantly because they both offer useful guidance.

Packaging

Manufacturers Turn to In-House Packaging
Daphne Allen

Many medical device manufacturers are bringing their packaging processes in-house, according to a recent study.

Software

Roadblocks on the Medical Superhighway?
Romina Vitols

Thanks in large part to computer-aided medical devices and decision-support software, it's only a matter of time before full-scale telemedicine is common practice.

Packaging

International Conference to Highlight European Union Markets
Daphne Allen

Medical device packagers and manufacturers interested in the European market will soon have the chance to learn about that region's packaging and sterilization issues.

Business

FDA and the Cost of Healthcare
Ronald C. Allen

As the Clinton administration and Congress grapple with finding ways to reduce the cost of healthcare, both have overlooked FDA, the one government agency that causes healthcare costs to rise continually.

Quality

The Future of Medical Device Regulation: A Global Perspective
Gordon Higson

In the decade ahead, Gordon Higson envisions a globally harmonized system for regulating medical devices, one based on a comprehensive, coherent set of standards.

Washington Wrap-up

When Cultures Collide: The Summit Story at FDA
James G. Dickinson

Two opposing cultures collide whenever FDA and industry meet. Most of the time the impact is gentle, with each side respecting the other's difference. But occasionally the impact results in a real explosion.

Business & Marketing

Redefining Product Value in Today's Market
Candace Littell

Unprecedented changes in healthcare financing and delivery are reshaping the way that healthcare providers view the role of medical technology in patient care.

Regulatory Affairs

FDA's Resurrected Device Classification Program
Charles H. Kyper

Device classification is a cornerstone of the Medical Device Amendments of 1976. It is intended to establish the lowest level of regulatory control that still provides reasonable assurance of a device's safety and effectiveness.

Manufacturing

Meeting FDA Process Validation Requirements
Ashweni Sahni and Curtis L. Larsen

Process validation is required to meet the current GMP regulation for medical devices. Publications and conferences on the subject have helped manufacturers to understand FDA's expectations, but there is still some confusion about what will satisfy FDA inspectors.

Software

Implementation of Design Controls Offers Practical Benefits
Daniel P. Olivier

A major change in FDA's proposed revision of the GMP regulation is the addition of design controls.