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The QMSR became effective February 2, 2026, replacing 21 CFR Part 820 as the foundation for medical device quality systems in the United States. While the two-year transition period allowed manufacturers to prepare, many organizations are still working to fully align their quality systems with QMSR requirements and ISO 13485:2016 expectations. Whether you're just beginning your transition or refining an implementation already underway, a systematic roadmap helps you priorit

Biocompatibility evaluation sits at the intersection of product safety, regulatory compliance, and quality system management. Under the QMSR , which incorporates ISO 13485:2016 by reference, biocompatibility must be fully integrated into your quality management system—not treated as a standalone testing exercise conducted outside your design and risk management processes. The publication of ISO 10993-1:2025 adds complexity and opportunity. The new standard's risk-based biol

The FDA medical device databases form an interconnected ecosystem that supports classification decisions, biocompatibility strategy, regulatory submissions, and ongoing compliance. If you understand what each database contains, you can move from guesswork to a traceable, defensible regulatory approach. Core FDA Device Databases Devices@FDA  provides information on cleared and approved devices, including marketing pathway, product codes, and approval or clearance documentation

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

Extractables and leachables analysis sits at the core of modern biocompatibility assessment for medical devices. If your device uses polymers, adhesives, colorants, tubing, coatings, or packaging, you are dealing with potential chemical migrants that regulators expect you to understand and control. What Are Extractables and Leachables? Extractables  are chemical constituents that move out of a device or material under aggressive laboratory conditions, such as exaggerated temp

Medical device biocompatibility evaluation involves two distinct but complementary approaches: chemical characterization and biological testing. Understanding when each is required—and how they work together—is essential for efficient regulatory submissions and comprehensive safety evaluation. Many manufacturers struggle with determining the appropriate balance between these approaches. Over-reliance on biological testing can miss critical chemical safety concerns, while foc

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