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Stay informed about key processes for Medical Devices and the latest FDA updates tailored for manufacturers.
Recent posts
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
5 days ago5 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 152 min read
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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
5 days ago5 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 152 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 263 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 292 min read
Cybersecurity for Medical Devices: what you need to know to meet the FDA's 2025 Guidance
Understand the FDA’s 2025 cybersecurity requirements for medical device submissions. Learn what manufacturers must include for successful FDA clearance.
SANRUBIO, LLC
Jul 43 min read
📱 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
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