House Reprocessed Medical Device Bill May Have Smoother Sailing
This article was originally published in The Gray Sheet
Executive Summary
Bipartisan support could help facilitate the progress of reprocessed single-use medical device legislation pending in the House during the next congressional session, Hill staffers predict.
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Reprocessors, OEMs Will Operate On "Level Playing Field," Feigal Testifies
FDA Center for Devices and Radiological Health Director David Feigal promised the House Commerce/ Oversight and Investigations Subcommittee Feb. 10 that new regulations on reuse of single-use devices will be equally applied to manufacturers and reprocessors.
Reprocessors, OEMs Will Operate On "Level Playing Field," Feigal Testifies
FDA Center for Devices and Radiological Health Director David Feigal promised the House Commerce/ Oversight and Investigations Subcommittee Feb. 10 that new regulations on reuse of single-use devices will be equally applied to manufacturers and reprocessors.
Reuse of single use devices
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"