21 CFR Part 812 — Investigational Device Exemption (IDE)
21 CFR Part 812 implements FD&C Act § 520(g) and governs the conduct of clinical investigations involving unapproved medical devices in the USA.
Structure of Part 812
| Subpart | Content |
|---|---|
| Subpart A (§§ 812.1–812.10) | General provisions — applicability, exemptions, labelling |
| Subpart B (§§ 812.18–812.38) | IDE application to FDA — contents, approval, supplements |
| Subpart C (§§ 812.40–812.48) | IRB review and approval |
| Subpart D (§§ 812.60–812.70) | Responsibilities of sponsors |
| Subpart E (§§ 812.100–812.119) | Responsibilities of investigators |
| Subpart F (§§ 812.140–812.150) | Records and reports |
| Subpart G (§§ 812.160–812.176) | FDA review of IDE applications |
Significant risk (SR) vs non-significant risk (NSR)
Significant risk (SR) devices
Devices that present a potential for serious risk to the health, safety, or welfare of a subject. SR device investigations require:
- A full IDE application submitted to and approved by FDA (§ 812.20)
- IRB approval
- Informed consent of subjects
- Compliance with all Part 812 requirements
FDA review timeline: 30 calendar days for initial IDE application.
Non-significant risk (NSR) devices
NSR device investigations do not require an IDE application to FDA — they only require:
- IRB approval under an abbreviated IDE (§ 812.2(b))
- Labelling as investigational
- Informed consent
IDE application contents (§ 812.20(b))
A complete IDE application must include:
- Name and address of sponsor
- Complete report of prior investigations (pre-clinical and clinical)
- Investigational plan (protocol, rationale, objectives, device description, monitoring procedures)
- Manufacturing description
- List of investigators and IRBs
- Agreement signed by each investigator
- Certification of IRB approval
- Informed consent procedures
- Financial disclosure information
Sponsor responsibilities (Subpart D)
Sponsors must:
- Select qualified investigators
- Monitor the investigation to ensure compliance
- Maintain records and make required reports to FDA (including unanticipated adverse device effects)
- Submit IDE supplements for changes to the protocol or device