MedTech Terms
    The authoritative reference
    All terms

    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 this means in practice

    RTA decisions waste valuable review cycles. Common triggers include missing performance data, inadequate cybersecurity content, and labeling deficiencies.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2RAPS·1
    1. 1
      510(k) RTA Policy
      Verified
      FDAfda.gov
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

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