SUDs (single-use devices) questions on US adverse event forms "within 6 months"
This article was originally published in Clinica
Executive Summary
US hospitals and manufacturers have been given a six-month grace period to alter their adverse event reporting systems before they must file a revised MedWatch form with the FDA. The agency ordered the changes in both the mandatory and voluntary adverse event reporting forms to comply with a provision of the Medical Device User Fee and Modernization Act.