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FDA Plans Guidance on Device Enhancement versus Recall

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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.
International Medical Device Regulatory Monitor