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    Refuse to Accept

    FDA administrative decision that a submission is incomplete and won't be substantively reviewed.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Refuse to Accept (RTA) is FDA's administrative review of 510(k) submissions to determine whether they meet a minimum threshold of acceptability for substantive review based on a checklist.
    What the regulation says
    The FDA conducts a Refuse to Accept (RTA) review for 510(k) submissions, as outlined in "Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff." This initial administrative assessment determines if a submission is complete enough to proceed to a substantive review, examining whether it meets basic requirements rather than evaluating scientific merit. Similarly, the FDA also applies RTA principles to De Novo and PMA submissions, each with specific guidance documents detailing the acceptance criteria.

    What this means in practice

    RTA decisions occur in the first 15 calendar days of the review clock. If FDA finds missing checklist items, the submission is held (RTA hold) and the 90-day review clock stops until the sponsor submits the missing content. Two consecutive RTA holds can effectively add 60 to 120 days to the timeline. Similar acceptance reviews exist for De Novo (Acceptance Review) and PMA (Filing Review). The most common RTA triggers in 2024-2025 have shifted from labeling and administrative gaps to cybersecurity content: missing SBOM, no threat model, no vulnerability management plan, no coordinated disclosure policy under Section 524B.

    Examples

    • A connected wearable 510(k) is held RTA on day 12 because the SBOM only lists top-level components without transitive dependencies, and no CVD policy is documented.
    • A traditional Class II 510(k) is held RTA because the indications for use statement in Section 4 does not match the labeling in Section 12.
    Common pitfalls
    • •Ignoring the eCopy or eSTAR technical validation errors before submission. Technical failures cause immediate RTA.
    • •Treating cybersecurity content as optional for 510(k). Under 524B, any cyber device submission without SBOM, CVD policy, and vulnerability management triggers RTA.
    • •Inconsistent indications-for-use wording across the cover letter, Section 4, and labeling. This is the single most common non-cyber RTA reason.
    • •Submitting near a quarter-end deadline without a full internal RTA checklist review. FDA follows the checklist strictly; sponsors should too.

    Frequently asked questions

    FDA completes the RTA review within 15 calendar days of receipt. If accepted, the substantive review clock starts on day 16. If held, the clock stops until the sponsor submits the missing content, at which point a new 15-day RTA cycle begins on the corrections.

    Related terms

    Shared paths + category
    Regulatory
    De Novo Classification Request(De Novo)

    Pathway to classify novel low- to moderate-risk devices that lack a predicate.

    510(k) Fundamentals · adjacent
    Regulatory
    510(k) Premarket Notification(510(k))

    FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

    510(k) Fundamentals
    Cybersecurity
    Premarket Cybersecurity Submission

    The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.

    FDA Cybersecurity 101
    Cybersecurity
    Section 524B of the FD&C Act(524B)

    The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices.

    FDA Cybersecurity 101
    Regulatory
    eSTAR

    FDA's interactive PDF template for preparing and submitting 510(k) and De Novo submissions.

    Same category
    Regulatory
    Premarket Approval(PMA)

    FDA's most stringent device marketing application, required for high-risk Class III devices.

    Same category

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    Primary references

    3 sources
    Link health: 2 verified 1 unchecked· last checked 2026-06-20
    FDA·2RAPS·1
    1. 1
      FDA 510(k) RTA Policy (final guidance)
      Verified
      FDAfda.gov
    2. 2
      Acceptance Review for De Novo Classification Requests
      Unchecked
      FDAfda.gov
    3. 3
      RAPS Regulatory Focus
      Verified
      RAPSraps.org

    Inline markers like [1] jump to the matching reference above.