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FDAnews Device Daily Bulletin
Oct. 8, 2012 | Vol. 9 No. 197
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, a CDRH 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,” CDRH Office of Compliance Director Steven Silverman said Sept. 21.
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