On February 2, 2026, FDA retired the Quality System Inspection Technique (QSIT) and implemented a new inspection process described in Compliance Program 7382.850 . This change represents more than updated procedures—it reflects a fundamental shift in how FDA assesses medical device quality management systems under the QMSR. For manufacturers and CROs, understanding the new inspection approach and preparing your quality system for FDA review is essential for maintaining compli

As of February 2, 2026, the FDA's Quality Management System Regulation (QMSR) has replaced 21 CFR Part 820 as the foundation for medical device quality systems in the United States. This transition incorporates ISO 13485:2016 by reference, harmonizing U.S. requirements with international quality management standards used by regulatory authorities worldwide. For medical device manufacturers, CROs, and regulatory affairs professionals, understanding what changed is essential fo

Bringing a medical device to the U.S. market means more than selecting a regulatory pathway. Your specific role shapes how you plan, generate, and defend biocompatibility and toxicological data within the FDA framework. Understanding Your Role in the Medical Device Approval Process Medical Device Manufacturers Manufacturers need a clear biocompatibility and toxicology strategy that starts at design input. Key challenges include: Translating intended use and contact duration

Medical device regulation in the United States sits squarely under the authority of the Food and Drug Administration, within the Center for Devices and Radiological Health (CDRH). If you plan to market a device in the U.S., you operate within this framework whether your product is a simple external accessory or an implantable system with long term patient contact. CDRH implements federal laws such as the Federal Food, Drug, and Cosmetic Act (FD&C Act) through binding regulat

Total medical compliance within the medical device industry refers to the complete and ongoing alignment of device development, testing, manufacturing, and post-market practices with regulatory and scientific standards that protect patient health and ensure market readiness. It encompasses far more than OSHA and HIPAA requirements. This is not about general workplace safety or patient data security. This is about biological safety and device functionality at the most granular

The regulatory landscape for medical devices is evolving rapidly, and ensuring compliance with the set regulatory standards is vital for...