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    IDE Annual Progress Report

    Annual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

    Definition

    Under 21 CFR 812.150(b)(5), IDE sponsors must submit a Progress Report to FDA at least yearly, summarizing the conduct of the investigation. Required content includes enrollment status (subjects enrolled, completed, withdrawn), summary of adverse events and UADEs, deviations from the investigational plan, sponsor monitoring activities, IRB activity (approvals, suspensions, terminations), and any other information relevant to the rights, safety, or welfare of subjects. Reports are due to FDA on the anniversary of the IDE approval and to reviewing IRBs at the frequency the IRB requires.
    What the regulation says
    21 CFR 812.150(b)(5) defines content and timing. FDA's BIMO Compliance Program 7348.811 (Sponsors, Contract Research Organizations, and Monitors) is the inspection reference.

    What this means in practice

    IDE annual reports are routinely reviewed by FDA bioresearch monitoring (BIMO) inspectors and are a leading source of Form 483 findings when content is incomplete or late. Sponsors should treat annual report preparation as an opportunity for portfolio-level oversight: cross-site enrollment trends, deviation patterns, and AE rates often reveal study conduct issues that warrant intervention before the next report.
    Common pitfalls
    • •Missing the annual deadline, reports are due on the anniversary of IDE approval, not the calendar year.
    • •Reporting only aggregate counts without trend analysis, sponsors are expected to interpret, not just summarize.
    • •Treating the annual report as administrative, it is a sponsor compliance artifact reviewed by FDA inspectors.

    Related terms

    Shared paths + category
    Clinical & Trials
    IDE Supplement

    Amendment to an approved Investigational Device Exemption for protocol or device changes.

    Clinical Trials & Evidence · adjacent
    Clinical & Trials
    Investigational Device Exemption(IDE)

    FDA authorization to use an investigational device in a clinical study.

    Clinical Trials & Evidence
    Clinical & Trials
    Investigator Brochure(IB)

    Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations.

    Clinical Trials & Evidence
    Clinical & Trials
    Protocol Deviation

    Departure from the approved clinical investigation plan.

    Clinical Trials & Evidence
    Clinical & Trials
    Unanticipated Adverse Device Effect(UADE)

    Any serious adverse effect on health or safety in an IDE study not previously identified in the investigational plan, triggers strict reporting timelines.

    Same category
    Post-Market
    Post-Market Surveillance(PMS)

    Activities to monitor device safety and performance after market release.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1FDA·2
    1. 1
      21 CFR 812.150 - Reports
      Verified
      eCFRecfr.gov
    2. 2
      FDA IDE Reports Guidance
      Verified
      FDAfda.gov
    3. 3
      FDA - Clinical Trials and Human Subject Protection
      Verified
      FDAfda.gov

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