Reuse of single use devices
This article was originally published in The Gray Sheet
Executive Summary
FDA's proposed strategy for regulating reuse of single use medical devices "would continue to ignore the [Food, Drug and Cosmetic Act] and leave patients at risk," the Association of Disposable Device Manufacturers maintains in a Nov. 19 letter to Rep. Fred Upton (R-Mich.). The association expresses support for H.R. 3148, introduced Oct. 26 by Anna Eshoo (D-Calif.) and Upton (1"The Gray Sheet, Nov. 1, p. 6), which "will motivate the FDA to protect U.S. patients from reprocessed single use devices"