What 21 CFR Part 812 - Investigational Device Exemptions (IDE) requires
21 CFR Part 812 sets out the FDA Investigational Device Exemption (IDE) requirements that permit a device that would otherwise require marketing clearance or approval to be shipped lawfully for the purpose of conducting a clinical investigation to collect safety and effectiveness data. The requirements turn on whether the device is a significant risk device or a nonsignificant risk device. A sponsor must submit an IDE application to FDA before beginning an investigation that uses a significant risk device, that involves an exception from informed consent, or where FDA requires an application, and must not begin until FDA has approved the application. The application must include an investigational plan stating the purpose, a scientifically sound protocol, a risk analysis, a description of the device, monitoring procedures, labeling and informed-consent materials. A sponsor may not begin an investigation until both the reviewing Institutional Review Board (IRB) and FDA have approved it. Sponsors are responsible for selecting qualified investigators, ensuring proper monitoring, obtaining IRB review, and promptly informing IRBs and FDA of significant new information; on discovering noncompliance or an unanticipated adverse device effect that presents an unreasonable risk, the sponsor must secure compliance or terminate the investigation, terminating within 5 working days of determining unreasonable risk. Investigators are responsible for conducting the investigation according to the signed agreement, the investigational plan and FDA regulations, protecting subjects, obtaining informed consent, and submitting reports, including reporting an unanticipated adverse device effect to the sponsor and reviewing IRB within 10 working days.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/part-812
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Primary Citations — 8 traced to source
- 21 CFR Part 812, §812.2 - applicability and significant risk / nonsignificant risk device categories
- 21 CFR Part 812, §812.20 - IDE application submission; an investigation requiring FDA approval may not begin until FDA approves the application
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