An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a PMA or 510(k) submission to FDA. Under 21 CFR Part 812, significant risk studies need FDA approval of the IDE application and IRB approval before enrolling, while non-significant risk studies need only IRB approval and abbreviated requirements. FDA has 30 days to respond to an IDE application. Sponsors must control device distribution, keep records, submit progress reports and report unanticipated adverse device effects.

Why it matters

Significant risk (SR) device studies require an FDA-approved IDE and IRB approval. Non-significant risk (NSR) studies require IRB approval and abbreviated IDE requirements.

Common pitfalls

•Failing to distinguish between significant risk and non-significant risk device studies can lead to incorrect application of IDE regulations.
•Assuming that IRB approval alone is sufficient for all investigational device studies, neglecting FDA IDE requirements.
•Not understanding the abbreviated IDE requirements for non-significant risk devices can result in unnecessary administrative burden.
•Improperly classifying a device's risk can lead to non-compliance with FDA regulations for clinical investigations.
•Beginning a clinical study without proper IDE approval or exemption can result in regulatory action by the FDA.

Sources

21 CFR Part 812 · eCFR
ISO 14155 Standard Page · ISO
FDA - Clinical Trials and Human Subject Protection · FDA

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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