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Stay informed about key processes for Medical Devices and the latest FDA updates tailored for manufacturers.
Recent posts
How to Market Medical Devices in the U.S.: Key FDA Insights
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.
SANRUBIO, LLC
Aug 214 min read
Navigating the FDA 2026 Human Factors Guidance: The Risk-Based Approach
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
SANRUBIO, LLC
Jun 93 min read
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Key differences between the 510(k) and De Novo submission for FDA Medical Device Authorization
Discover the key differences between FDA’s 510(k) and De Novo pathways for medical device authorization. Learn when to choose each option, their requirements, timelines, and ideal use cases. From substantial equivalence in 510(k) to creating new classifications in De Novo, this guide provides essential insights for manufacturers. Ensure regulatory success with expert strategies and tailored support for your device’s U.S. market entry.
SANRUBIO, LLC
Jun 17, 20253 min read
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