FDA Issues Draft Guidance on Distinguishing Device Recalls from Product Enhancements

The Food and Drug Administration said a draft guidance on distinguishing device recalls from product enhancements is now available. The guidance would clarify when a change to a device meets the definition of a recall, and whether FDA should be notified. Device improvements do not necessarily mean old versions of a device need to be recalled, FDA said, but when the new version of a device corrects an identified defect or failure the public should be notified without delay. Comments on the draft guidance are due by May 23.