Medical Device Link.

May 1999 MD&DI
Selected Contents

COVER STORY:
Flow Control: Metering Fluids in Medical Devices
by Eric Pepe and George Halfinger

Proper pump selection is key to achieving efficient flow control in medical devices that handle fluids.

ELECTRONIC SIGNATURES:
Understanding FDA's Electronic Records and Signatures Regulation
by Jeffrey N. Gibbs and Kate Duffy Mazan

The implementation of FDA's 1997 rule raises legal and regulatory issues for device companies.

CE MARKING:
From FDA Quality System Regulation to CE Marking
by Ron Belmont, Carrie Hartill, and James W. Kolka

Awareness of the similarities and differences between U.S. and EU regulatory systems can help manufacturers satisfy both regimens and meet CE marking requirements.

RADIOPAQUE COATINGS:
Critical Insight: Marking Devices with Radiopaque Coatings
by Richard Sahagian

New technologies for applying radiopaque coatings enable products such as stents, catheters, and guidewires to be easily seen on x-rays and fluoroscopes during critical interventional procedures.

LABELING:
Medical Device Labeling in the European Union
by Larry R. Pilot

The five-year transition period has passed since the implementation of the Medical Devices Directive, and products must meet its essential requirements before they can earn the CE mark and be sold in the EU market.

VALIDATION:
Sterilization Validation of an Isolator System
by Anne F. Booth

Manufacturers who use vapor phase hydrogen peroxide–sterilized isolators need to take a comprehensive, ongoing systems approach to validation.

LASERS:
Covering the Spectrum
by Kevin J. Ely

Lasers meet wide-ranging requirements for welding and drilling applications in medical manufacturing.

SPECIAL SECTION:
The Dow Corning Siloxane Research Program: An Overview and Update
by Robert G. Meeks

Started in 1993, an ongoing series of studies examines the acute and long-term safety of exposure to the fundamental building blocks of many silicone materials.

FIRST PERSON:
FDA/Industry Partnerships: Moving toward More Equitable Enforcement
by Nancy Singer

Reversing what was often an adversarial relationship, FDA has worked with representatives of the device industry to implement changes designed to improve the agency's inspection and enforcement policies.

WASHINGTON WRAP-UP:
File Closes on Document Leak
by James G. Dickinson

Final investigation leaves key questions unresolved.

R&D HORIZONS:
A Slice of the Future: CT Harnesses New Technologies
by Greg Freiherr

Developments in computed tomography have the potential to dramatically alter current medical practice and reinvigorate a lethargic imaging market.

BOTTOM LINE:
Finding a Safe Harbor: Anti-Kickback Implications of Medical Device Consulting Agreements
by Peter Spivack

To avoid violating government bribery regulations, device companies need to be extremely careful in planning, drafting, and monitoring consulting agreements with physicians who use their products.

SNAPSHOT:
Part Analyst, Cheerleader, and Visionary, Ron Sparks is Scoping Out the Future
by Jennifer M. Sakurai

EDITOR'S PAGE:
Casting an Interactive Web: Henney Seeks Real-Time Input from Industry
by John Katz

Will new media help implement FDAMA's mandate for engagement and interaction between FDA and device companies? A recent event tests a powerful mechanism for dialogue.