Times R A'changin': FDA Perspectives on Use of Open Source

• Activity Number: 51
• Type: Topic Contributed
• Date/Time: Sunday, August 6, 2006 : 4:00 PM to 5:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): B. Sue Bell*+ and Kathleen Morrish and Ferrin Harrison and David Petullo and Laura Thompson and Gerry W. Gray
• Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration and U.S. Food and Drug Administration and U.S. Food and Drug Administration and U.S. Food and Drug Administration and U.S. Food and Drug Administration
• Keywords: open source ; freeware

Abstract

In August 2003, the FDA issued "Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application." The FDA explains it is re-examining Part 11 and intends to interpret its scope narrowly. It recognized that earlier drafts risked discouraging innovation and technological advances without providing a significant public health benefit. Meanwhile, the National Cancer Institute's caBIG (cancer Biomedical Informatics Grid) initiative applies open-source, open-development principles. This talk will provide a brief history of how FDA's perspectives have evolved over time, discuss the internal environment of how FDA scientists are permitted limited access to software that is not "commercial off the shelf" (COTS), and discuss implications for regulatory submissions based on software that is not COTS.