April 2001
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S PAGE:
Several major in vitro diagnostics companies have come together to develop a standards proposal for the connectivity of point-of-care devices. Their labor provides a model for other manufacturers seeking to expedite the standards development process.
WASHINGTON WRAP-UP:
R&D HORIZONS:
Data from three studies suggest that using trimellitates can reduce the amount of plasticizer that may migrate from PVC devices.
INSIDE MD&DI In this month's special in vitro diagnostics supplement ("Regulating the Point of Care: The IVD Connectivity Industry Consortium"), Alan Reder outlines the efforts of a group of point-of-care (POC) device manufacturers—the Connectivity Industry Consortium (CIC)—to develop a connectivity standard for the POC industry.
Director's Cut: CDRH Chief Extends Himself
Jon Katz
CDRH director David Feigal conceives the quest for safety and effectiveness as a cooperative venture with industry for mutual success.
COVER STORY:
Regulating the Point of Care: The IVD Connectivity Industry Consortium
Alan Reder
Legal Liabilities of Medical Device Outsourcing
Larry R. Pilot and Donald R. Stone
Contracting for the manufacture of a product does not relieve the developer of many legal responsibilities. Both developer and manufacturer can have FD&C law and product liability exposure.
Dip Molding of Polyurethane and Silicone for Latex-Free, Nonallergenic Products
Tilak M. Shah
As more healthcare facilities require latex-free products to minimize the risk of allergic reactions among patients and staff, the demand accelerates for alternative elastomeric materials.
An FDA Veteran's Toughest Device Approval
James G. Dickinson
Final labeling includes more indications than originally requested.
Concurrent Engineering and Partnerships Reduce Time, Cost
Ellen Pauli
Approaching concurrent engineering as a mind-set enables design and manufacturing teams to bring products to market sooner.
MEDICAL PLASTICS &
BIOMATERIALS:
A Comparison of Plasticizers for Use in Flexible Vinyl Medical Products
Richard C. Adams
A Reality Check for Device Manufacturers
Robert Drummond
