On April 23, 2026, the Centers for Medicare & Medicaid Services (CMS) and the FDA announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, a groundbreaking initiative designed to accelerate Medicare beneficiary access to FDA-designated Breakthrough Devices. Combined with the expanding Total Product Life Cycle Advisory Program (TAP), these programs fundamentally change how manufacturers should approach development strategy, evidence gen

Contract research organizations occupy a unique position in the medical device ecosystem. While CROs don't typically hold FDA establishment registrations as manufacturers, the quality of services they provide directly impacts their clients' QMSR compliance, biocompatibility evaluations, and regulatory submissions. The QMSR's emphasis on process-based quality management, expanded FDA inspection authority, and integration of biocompatibility with design controls creates both ch

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

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

Navigating the complex world of medical device biocompatibility can be overwhelming for manufacturers. With stringent regulatory...

When it comes to manufacturing medical devices, ensuring safety and compliance is paramount. Navigating complex regulatory landscapes can...

What exactly are chemical characterization consulting services, and why do you need them?

Today, from diagnosis to management of diseases, in vitro diagnostics (IVDs) and medical devices play a significant role. To ensure the...