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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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📱 Developing Home-Use Medical Devices: FDA regulations, design, and usability considerations
Learn how to develop FDA-compliant home-use medical devices with a focus on usability, safety, and effective regulatory strategies. This guide covers key FDA guidelines, including human factors engineering, IEC 62366-1 standards, and essential elements for a successful 510(k) submission. Discover best practices and how Sanrubio, LLC, based in Miami, can assist with pre-submission planning and FDA approval to streamline your market entry
SANRUBIO, LLC
Jun 303 min read
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
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 84 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 303 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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