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Stay informed about key processes for Medical Devices and the latest FDA updates tailored for manufacturers.
Recent posts
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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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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