IVD Technology

November/ December 1997
Selected Contents

Cover Story: The changing regulatory climate for blood establishments and their vendors
by David F. Weeda, Stephen D. Terman, and Neil F. O'Flaherty

FDA's regulatory oversight of blood-bank software has grown rapidly in a relatively short time — possibly outpacing the ability of blood establishments, vendors, and the agency itself to address relevant issues effectively.

Formal experimental design and analysis for immunochemical product development
by John A. Wass

Part 2: Using commercially available software, product developers can implement well-accepted statistical and computational algorithms that can help to streamline the development of new products.