Bioterrorism jurisdiction
This article was originally published in The Gray Sheet
Executive Summary
FDA is reexamining its role in regulating environmental screens for biological toxins, attorney Jeffrey Gibbs, Hyman, Phelps & McNamara, says at a FDLI-sponsored conference Feb. 20. Though CDRH does not generally consider environmental detection products to be medical devices, the agency has asked manufacturers for information about tests that claim to "detect anthrax spores," for example, in contrast to tests that "diagnose anthrax." CDRH Director David Feigal indicated in November 2001 that the agency was interested in investigating the regulatory jurisdiction for environmental tests (1"The Gray Sheet" Nov. 26, 2001, p. 8). Gibbs also says that FDA should choose not to exercise its power to regulate counter-bioterrorism devices, taking a "hands-off" approach similar to the agency's stance on laboratory-developed "home brew" tests...