"Home brew" IVD policy
This article was originally published in The Gray Sheet
Executive Summary
Washington, D.C. law firm of Fox, Bennett & Turner submits comments to FDA Dec. 16 urging the agency to withdraw its proposal to regulate laboratories' in-house in vitro diagnostics. The law firm argues that laboratories already are regulated under the Clinical Laboratory Improvement Amendments of 1988 and that FDA lacks authority to oversee labs' in-house activities. Fox, Bennett also expresses support for an Oct. 22 petition submitted by the Washington, D.C. law firm Hyman, Phelps & McNamara that called for reversal of the proposed policy ("The Gray Sheet" Nov. 2, p. 3)....