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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​

SubpartContent
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, as defined in 21 CFR § 812.3(m). This includes devices that are permanently implanted, are used in life-sustaining or life-enhancing functions, or present significant questions regarding biocompatibility. 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

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

Official resources​

If FDA has objections to an IDE application within the 30-day period, the sponsor is notified and the IDE is not approved until concerns are resolved. FDA may request additional information or modifications to the investigational plan. The review clock pauses while the sponsor responds to FDA questions.