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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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What is Elsa and what has the FDA recently announced?
The FDA has introduced Elsa, a new AI tool designed to assist in medical device reviews, enhancing efficiency in 510(k), De Novo, and PMA pathways. Elsa operates securely without using confidential manufacturer data, aiming to speed up reviews and improve accuracy. While still early in development, it encourages manufacturers to prepare AI-ready submissions. This innovation marks a key step toward AI integration in regulatory processes, with ongoing human oversight and transp
SANRUBIO, LLC
Jun 9, 20254 min read
510(k) Submission with the eSTAR template: processing times.
The FDA Premarket Notification (510(k)) is essential for medical device manufacturers entering the U.S. market. It demonstrates that a new device is substantially equivalent to an existing, legally marketed device (predicate device) in terms of intended use and technical characteristics. Using the FDA's eSTAR template (mandatory as of October 1, 2023), the 510(k) process ensures device safety, effectiveness, and regulatory compliance. SANRUBIO, LLC offers expert guidance for
SANRUBIO, LLC
May 30, 20253 min read
Transformation of the FDA's Medical Device Quality Management System Regulation – QMSR Regulation
Transformation of the FDA's Medical Device Quality Management System Regulation – QMSR Regulation
SANRUBIO, LLC
Nov 21, 20242 min read
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