FDA Nixes Baseline Reports

Full brief reprinted from "The Gray Sheet" - June 16, 2008

Find out what form the FDA's June 13, 2008 final rule has eliminated.

Device firms no longer need to submit an extra form detailing basic product information - including product code, shelf life and manufacturing address - with FDA adverse event reports, according to a final rule issued June 13. Companies have been required since 1995 to submit the so-called "baseline reports" along with a product's first adverse event report and then to update the baseline report annually. FDA has since revised its MedWatch adverse event reporting form to collect additional information, making the baseline reports redundant.