Navegar la ruta regulatoria de la FDA exige una estrategia clara. Esta guía detalla la clasificación por riesgo con ejemplos reales, desglosa las vías 510(k), De Novo y PMA, cubre herramientas obligatorias de la FDA como eSTAR y la QMSR (ISO 13485) y explica los requisitos de Registro de Establecimiento y Listado de Dispositivos para comercializar sin contratiempos en EE. UU.

On May 29, 2026, the FDA issued its final guidance on the Content of Human Factors Information in Medical Device Marketing Submissions. This risk-based framework introduces three HF Submission Categories based on critical tasks and device changes. It helps manufacturers streamline CDRH submissions, clarifying when a simple summary suffices versus when comprehensive validation testing is mandatory, improving FDA review efficiency

As of February 2, 2026, the FDA has officially replaced the old Quality System Regulation (21 CFR 820) with the new Quality Management System Regulation (QMSR). This historic alignment with ISO 13485:2016 streamlines global compliance for medical device manufacturers. This article explores the core changes, the additional FDA-specific requirements, and how this "single audit" reality reduces costs and accelerates market access for international firms.

The FDA updates its real-world evidence policy for medical devices by removing the routine requirement for identifiable patient data. This change expands the regulatory use of de-identified databases and reshapes evidence strategies for medical device manufacturers seeking FDA clearance or approval.

Launching medical devices in the U.S. market requires a critical strategic decision: choosing the correct regulatory pathway with the FDA . This decision will significantly impact timing, costs, and commercial viability. In this post, we explain when it’s most appropriate to use the 510(k) , De Novo , or PMA route and how regulatory consulting from Sanrubio, LLC can help you make the correct decision. How to Choose the Right Regulatory Pathway for Your Medical Devices: 510(

The U.S. Food and Drug Administration (FDA) mandates that all medical device establishments, whether based in the United States or exporting from countries like Mexico, Colombia, Argentina, or Brazil, renew their registration annually for the 2026 fiscal year. Governed by 21 CFR Part 807 , this process is mandatory for manufacturers, initial importers, specification developers, and distributors marketing medical devices in the U.S. market. The renewal must be completed betwe