FDA· Jul 10, 2026
Mining FDA Databases for Cybersecurity Precedent
A five-source workflow (510(k), De Novo, PMA, MAUDE, FOIA) for mining FDA cybersecurity precedent by product code before a Section 524B filing.
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De Novo articles.
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Showing 3 of 3 articles tagged De Novo
FDA Compliance· Jun 11, 2026
eSTAR v7.0 Cybersecurity for IVDs vs nIVD Submissions
eSTAR v7.0 cybersecurity slots are identical for IVD and nIVD submissions, but the content reviewers expect is not. Here's how to fill each section correctly.
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FDA· Apr 12, 2025
FDA 510(k), De Novo, and PMA Databases: Cybersecurity Guide
Search the FDA 510(k), De Novo, and PMA databases for cybersecurity precedent, product codes, and predicates before a Section 524B filing.
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