FDA Releases Draft Guidance on QMS Requirements in Premarket Submissions (October 2025)
U.S. FDA October 2025, released a draft guidance titled “Quality Management System Information for Certain Premarket Submission Reviews”. This document provides detailed instructions for medical device manufacturers and FDA staff on preparing and submitting Quality Management System (QMS) information as part of Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) applications.The guidance is designed to […]
IVDR (EU) 2017/746 Labeling Requirements: What IVD Manufacturers Need to Know
IVDR LABELING ESSENTIALS: EASY STEPS TO STAY COMPLIANT Under the IVDR (EU 2017/746), labeling is not just packaging text—it is a legal safety requirement. Your label and Instructions for Use (IFU) must clearly tell users what the device is, how to use it safely, and how to trace it through UDI. Manufacturers must follow these […]