FDA guides.
Every guide we've published on FDA.
37 guides tagged FDA
12 Reasons the FDA Rejects Cybersecurity Submissions
The most common deficiencies we see in 510(k), De Novo, and PMA cybersecurity packages - and how to avoid each one.
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Combination Product Cybersecurity: When CDER Meets CDRH §524B
Drug-device combination products (auto-injectors, on-body delivery, connected inhalers, prefilled pumps) trigger FDA cybersecurity requirements the drug side rarely sees. Here is how Section 524B, the Feb 2026 premarket guidance, and the CDER/CDRH lead-center split actually apply.
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Cyber Device Decision Tree (Are You In Scope of §524B?)
Is Your Device a 'Cyber Device'? A Decision Tree Walk through Section 524B's three-part test in five minutes.
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Cybersecurity Management Plan for FDA Submissions: A 2026 Guide
What goes in the Cybersecurity Management Plan reviewers expect in eSTAR v7.0 Slot 1: scope, governance, QMS integration, postmarket commitments, and the most common deficiency patterns.
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De Novo Cybersecurity Submission Guide
Learn the specific cybersecurity requirements for a successful De Novo submission. Ensure FDA compliance with threat modeling, SBOM, and pen testing.
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eSTAR Cybersecurity Readiness Checklist (510(k) & De Novo)
Map every cybersecurity control to the exact eSTAR section reviewers expect. A 20-point readiness checklist for 510(k) and De Novo submissions under the FDA's February 2026 final guidance.
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eSTAR v6.2 vs v7.0 Cybersecurity: What Actually Changed
Honest template-level diff of FDA eSTAR v6.2 and v7.0 for cybersecurity: the new Controls field, the August 3, 2026 retirement date, and what's template-enforced vs. guidance expectation.
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eSTAR v7.0 Cybersecurity Attachments: How the 8 Slots Map to the FDA's 2026 Guidance
Side-by-side mapping of the 8 Cybersecurity attachment slots in eSTAR v7.0 to the 15 deliverables in the FDA's February 2026 final guidance, with the most common RTA trigger per slot.
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EU MDR vs FDA Medical Device Cybersecurity: A Side-by-Side Crosswalk
How EU MDR/IVDR cybersecurity requirements compare to FDA Section 524B and the February 2026 guidance - Annex I §17.2, MDCG 2019-16, SBOM, vulnerability handling, and postmarket obligations.
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