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    Guides · FDA

    FDA guides.

    Every guide we've published on FDA.

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    18 guides tagged FDA

    Cover image for 12 Reasons the FDA Rejects Cybersecurity Submissions
    FDAReference

    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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    FDA article cover: Cyber Device Decision Tree (Are You In Scope of 524B?)
    FDAReference

    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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    Cover image for CycloneDX vs. SPDX: Choosing an SBOM Format for the FDA
    FDAReference

    CycloneDX vs. SPDX: Choosing an SBOM Format for the FDA

    Does the FDA prefer CycloneDX or SPDX? Compare SBOM formats for medical device cybersecurity compliance and premarket 510(k) submissions.

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    FDA article cover: eSTAR Cybersecurity Readiness Checklist (510(k) & De Novo)
    FDAChecklist

    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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    Cover image for FDA 524B Cybersecurity Requirements: A Compliance Guide
    FDAReference

    FDA 524B Cybersecurity Requirements: A Compliance Guide

    Master FDA 524B cybersecurity requirements. Learn how to meet SBOM, vulnerability monitoring, and patch management standards for medical device submissions.

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    Cover image for FDA Classification Decision Tree (Wellness vs. Device)
    FDAReference

    FDA Classification Decision Tree (Wellness vs. Device)

    250+ 0 6–10 wk FDA submissions supported Cybersecurity rejections Class II eSTAR cyber pack SINCE 2014 TRACK RECORD TYPICAL TIMELINE

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    Cover image for FDA Cybersecurity Deficiency Letter Examples & Analysis
    FDAReference

    FDA Cybersecurity Deficiency Letter Examples & Analysis

    Analyze real-world FDA cybersecurity deficiency letter examples. Learn how to address RTA and AI deficiency requests for 510(k) and PMA submissions.

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    Cover image for FDA Cybersecurity Deficiency Response Checklist
    FDAChecklist

    FDA Cybersecurity Deficiency Response Checklist

    Step-by-step checklist for responding to FDA cybersecurity deficiency letters without losing your submission timeline.

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    Cover image for FDA Cybersecurity Readiness Diagnostic Outline
    FDAReference

    FDA Cybersecurity Readiness Diagnostic Outline

    20-Minute Cyber Readiness Diagnostic Outline The exact agenda we run on a 20-minute discovery call so it produces a usable output.

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