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

FDA Recalls Guidance Seeks To Allay Manufacturer Anxieties About Device Safety Enhancements-graysheet: A new draft guidance tries to reassure manufacturers that they can make changes to improve a device's performance or safety without fear that FDA will necessarily require a recall.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.