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FDA Recalls Guidance Seeks To Allay Manufacturer Anxieties About Device Safety Enhancements

A new draft guidance tries to reassure manufacturers that they can make changes to improve a device's performance or safety without fear that FDA will necessarily require a recall. But early reactions suggest industry may not be happy with at least one component of the document.

FDA hopes a new draft guidance will ease industry jitters and encourage device firms to improve their products without fear that the existing versions will need to be recalled.

The Feb. 22 document reassures manufacturers that just because they change a device to improve its performance or safety "does not necessarily mean" that the existing device needs to be...

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