IRB review-type helper

Not a determination. US Common Rule / FDA IRB framework, simplified.

InterventionNo intervention (records / leftover samples, de-identified)Minimal-risk procedures (survey, blood draw within limits)Greater than minimal risk

Vulnerable populationAdults with capacity, not prisonersChildren, pregnant, prisoners, or impaired consent

Device investigationNot a device studyNon-significant-risk device (sponsor/IRB NSR)Significant-risk device / IDE

Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. IRB review-type helper does not submit to FDA, Notified Bodies, or IRBs.

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