21 CFR Part 812 — Investigational Device Exemptions

21 CFR Part 812 governs the conduct of clinical investigations of medical devices in the United States under Investigational Device Exemptions (IDEs). It establishes the procedures and requirements for sponsors and investigators to study devices that have not yet received market clearance or approval, balancing the need for clinical evidence with patient safety protections.

Overview

Background

Administered by the FDA under the Federal Food, Drug, and Cosmetic Act, Part 812 was established to provide a regulatory pathway for clinical evaluation of unapproved medical devices. It creates a framework that allows promising devices to be studied in human subjects while maintaining rigorous safety oversight through IDE applications and institutional review board (IRB) approval.

Applicability

This regulation applies to sponsors, investigators, and IRBs involved in clinical investigations of medical devices conducted in the United States. It covers both significant risk and nonsignificant risk device studies and defines the responsibilities of each party, including IDE application requirements, informed consent, monitoring, recordkeeping, and reporting obligations.

Core Principles

IDE application and approval process

Significant vs. nonsignificant risk device classification

Institutional Review Board oversight

Informed consent requirements

Sponsor responsibilities and obligations

Investigator responsibilities

Adverse event reporting and recordkeeping

Device accountability and disposition