Latex device labeling
This article was originally published in The Gray Sheet
Executive Summary
Combination products currently regulated under human drug or biologic labeling will not be subject to provisions of FDA's final rule requiring label statements for all medical devices that contain or have packaging that contain natural rubber that contacts humans, the agency says in a May 6 Federal Register notice. FDA "intends to initiate a proceeding to propose natural rubber labeling requirements for drugs and biologics, including combination products that are currently regulated under drug or biologic labeling provisions," the agency states in the notice, which is issued as an "interpretation" of its Sept. 30, 1997 final regulation on user labeling for medical devices containing natural rubber ("The Gray Sheet" Oct. 6, 1997, p. 3)...