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Stay informed about key processes for Medical Devices and the latest FDA updates tailored for manufacturers.
Recent posts
The QMSR Era: FDA’s Final Move to ISO 13485 Harmonization - Quality Management System and the FDA
As of February 2, 2026, the FDA has officially replaced the old Quality System Regulation (21 CFR 820) with the new Quality Management System Regulation (QMSR). This historic alignment with ISO 13485:2016 streamlines global compliance for medical device manufacturers. This article explores the core changes, the additional FDA-specific requirements, and how this "single audit" reality reduces costs and accelerates market access for international firms.
SANRUBIO, LLC
Mar 202 min read
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
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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 17, 20253 min read
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