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.
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 Required content includes enrollment status (subjects enrolled, completed, withdrawn), summary of adverse events and UADEs, deviations from the investigational plan, sponsor monitoring activities, IRB activity (approvals, suspensions,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 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.- •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
Grouped by themeEditor's picks
· Hand-selected related conceptsAmendment to an approved Investigational Device Exemption for protocol or device changes.
FDA authorization to use an investigational device in a clinical study.
Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations.
Departure from the approved clinical investigation plan.
Clinical Trials & Evidence
· From this learning pathBoard that reviews and approves human-subjects research at an institution.
Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Any untoward medical occurrence in a subject, whether or not related to the device.
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
Primary references
3 sources- 1
21 CFR 812.150 - ReportsVerifiedeCFRecfr.gov
- 2
FDA IDE Reports GuidanceVerifiedFDAfda.gov
- 3
FDA - Clinical Trials and Human Subject ProtectionVerifiedFDAfda.gov
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