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    Guides · FDA

    FDA guides.

    Every guide we've published on FDA.

    Format

    10 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 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 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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    Cover image for FDA Cybersecurity Submission Requirements Guide
    FDAReference

    FDA Cybersecurity Submission Requirements Guide

    FDA Cyber Requirements: The Law, the Guidance, the eSTAR A precise reference for what Section 524B requires and what the Feb 3, 2026 guidance expects.

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    Cover image for FDA Submission Cybersecurity Readiness Audit
    FDAReference

    FDA Submission Cybersecurity Readiness Audit

    Submission Readiness Self-Audit A pre-submission self-check covering every cyber attachment FDA expects.

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    Cover image for FDA Submission Track Record Reference Guide
    FDAReference

    FDA Submission Track Record Reference Guide

    Submission Track Record by Device Class & Pathway What we have supported, by class and pathway, with the kind of detail you can hand to procurement.

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    FDA article cover: Re-Engagement Sequence: Restarting a Stalled Cyber Program
    FDAReference

    Re-Engagement Sequence: Restarting a Stalled Cyber Program

    Re-Engagement Sequence (After Going Dark) A plain, no-pressure sequence to re-open a cybersecurity conversation after a quiet period.

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    Put the guides into action

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