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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.
Devices & Diagnostics Letter