Distributor use of MDR form 3500A encouraged but not required, FDA says in draft CPG.
This article was originally published in The Gray Sheet
Executive Summary
DISTRIBUTOR USE OF MEDWATCH FORM 3500A ENCOURAGED BUT NOT REQUIRED, FDA says in an Aug. 28 draft compliance policy guide. "Although the 3500A reporting form is not currently required for distributors, the FDA encourages distributors to use this form," the agency says, noting that this would "reduce the paperwork and level of effort" for distributors, manufacturers and FDA.