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The QMN Weekly Bulletin
Oct. 26, 2012 | Vol. 4 No. 43
FDA Plans Guidance on Device Enhancement versus Recall
The FDA plans to issue clarifying guidance to address confusion among devicemakers about what exactly constitutes an enhancement and what qualifies as a recall, an FDA official says. “Devicemakers have expressed concern that sometimes when a change to a product is made to make it safer, more effective and easier to use, the agency characterizes those changes as a recall — and they’re not recalls,” said Steven Silverman, director of the FDA’s Center for Devices and Radiological Health’s Office of Compliance.
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