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Stay informed about key processes for Medical Devices and the latest FDA updates tailored for manufacturers.
Recent posts
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 183 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 275 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 173 min read
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