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Stay informed about key processes for Medical Devices and the latest FDA updates tailored for manufacturers.
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FDA removes a major barrier to the use of real-world evidence in medical device reviews
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.
SANRUBIO, LLC
Dec 29, 20253 min read
How to choose the right regulatory pathway for your Medical Devices in FDA: 510(k), De Novo, or PMA
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(
SANRUBIO, LLC
Nov 18, 20253 min read
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FDA removes a major barrier to the use of real-world evidence in medical device reviews
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.
SANRUBIO, LLC
Dec 29, 20253 min read
How to choose the right regulatory pathway for your Medical Devices in FDA: 510(k), De Novo, or PMA
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(
SANRUBIO, LLC
Nov 18, 20253 min read
FDA 2026 Medical Device Establishment Registration Renewal: Complete Guide for Manufacturers and Importers
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
SANRUBIO, LLC
Oct 27, 20255 min read
AI-enabled mental health devices and emerging regulatory challenges
La FDA evalúa en 2025 los dispositivos mentales con inteligencia artificial, abriendo nuevos retos regulatorios. Fabricantes deben prepararse con estrategias sólidas de Pre-Sub, 510(k), De Novo o Breakthrough. Descubre cómo cumplir con los requisitos de la FDA y llevar tu dispositivo al mercado de EE. UU. con éxito.
SANRUBIO, LLC
Sep 15, 20252 min read
Medical device usability: FDA guidance and IEC 62366 as key allies for safety
At SanRubio, LLC we believe usability is essential to ensure that medical devices are not only effective but also safe. The way users...
SANRUBIO, LLC
Aug 26, 20253 min read
What is a Pre-submission (FDA) and why should manufacturers use it before filing a 510(k) or De Novo?
The FDA Pre‑Submission (Pre‑Sub) process is a strategic tool under the FDA’s Q‑Submission Program that allows medical device...
SANRUBIO, LLC
Jul 29, 20252 min read
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