Medical Device Link.

July 2000
MD&DI
Selected Contents

MEDICAL PLASTICS AND BIOMATERIALS
Breathable TPE Films for Medical Applications
by Larry Johnson and Dirk Schultze

By tailoring the hard- and soft-segment chemistry of thermoplastic elastomers, product designers can create films that satisfy the requirements of various protective medical products.

WASHINGTON WRAP-UP:
(Washington Wrap-Up) FDA's Plan for Web-Based Device Labeling
by James G. Dickinson

CDRH's goals for its home page enhancements include posting simple, clearly written device labeling on its site.

Also:

• A "Collective FDA-483"?
• Criticism Greets Breast Implant Approvals
• FDA Guidances for Special Controls
• FDA Raps Allergan over Lens Claims

Qualifying High-Speed Assembly Machines as Part of Process Validation
by Jan Schikora

Consideration of a few key elements can help manufacturers effectively manage assembly process qualification.

Latin American Medical Device Regulations
by Patricia M. Flood

Until Latin American countries move to a more general, harmonized regulation process, medical device companies wishing to market their products in the region will have to obtain country-specific approvals on a case-by-case basis.

MDEA AWARDS:
For Award-Winning Devices, the Healthcare Future Is Now
by Leslie Laine

The Medical Design Excellence Awards (MDEA) 2000 winners represent not only technological innovation and quality engineering but also major advances in healthcare.

EDITOR'S PAGE:
FORGE OF THE GODS: An Eruption of New Biomaterials
by Jon Katz

Attendees at the Sixth World Biomaterials Congress in Hawaii were exposed to a tremendous surge of new developments in the field, along with some traditional wisdom.