Section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 360j(g)] establishes a framework for FDA to a grant a device for investigational use an exemption from certain requirements, such as performance standards or premarket approval, for the purpose of conducting investigations of that device.
This exemption is known as an Investigational Device Exemption (IDE).
FDA is the final arbiter in deciding whether a device study poses a significant or nonsignificant risk and whether an IDE is required.
Sponsors must obtain FDA approval of an IDE application prior to beginning clinical investigations of significant risk devices if the clinical investigation is assessing the safety and effectiveness of the device.
FDA's Objectives in Reviewing an IDE
FDA has two primary objectives in reviewing an IDE: (1) to assure safety and appropriate patient protections for device trials and (2) assure that the risks to the subjects are outweighed by the anticipated benefits to the subjects and the importance of the knowledge to be gained (21 CFR 812.30(b)(4)).
An IDE is a regulatory submission that permits clinical investigation of devices to determine safety and effectiveness.
An FDA-approved Investigational Device Exemption Application (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device (21 CFR 812.1).
IDE Regulations are found in - Title 21 of the Code of Federal Regulations (CFR), Part 812 (21 CFR 812).
Guidance on IDEs is provided on the FDA web page .
IDE Regulations in Title 21 of the Code of Federal Regulations
IDE Regulations are found in Title 21 of the Code of Federal Regulations (CFR), Part 812
Regulations that apply to IDEs are found in 21 CFR as follows:
When is an IDE Required
View the ReGARDD decision tree to determine if an IDE is needed
Categories of IDE Study Types
IDEs fall into four categories:
Early Feasibility Study
An early feasibility study is a limited clinical investigation of a device early in development, typically before the device design has been finalized, for a specific indication (e.g., innovative device for a new or established intended use, marketed device for a novel clinical application). It may be used to evaluate the device design concept with respect to initial clinical safety and device functionality in a small number of subjects (generally fewer than 10 initial subjects) when this information cannot practically be provided through additional nonclinical assessments or appropriate nonclinical tests are unavailable. Information obtained from an early feasibility study may guide device modifications. An early feasibility study does not necessarily involve the first clinical use of a device.
Early Feasibility/FIH Clinical Considerations
First in Human (FIH) study
A first in human (FIH) study is a type of study in which a device for a specific indication is evaluated for the first time in human subjects. This document only discusses FIH studies that meet the definition of an early feasibility study.
Traditional Feasibility Study
A traditional feasibility study is a clinical investigation that is commonly used to capture preliminary safety and effectiveness information on a near-final or final device design to adequately plan an appropriate pivotal study. Because the study of a near-final or final device design takes place later in development than an early feasibility study, FDA would expect to see more nonclinical (or prior clinical) data in a traditional feasibility study IDE application. A traditional feasibility study does not necessarily need to be preceded by an early feasibility study.
A pivotal study is a clinical investigation designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use, typically in a statistically justified number of subjects. It may or may not be preceded by an early and/or a traditional feasibility study.
Pivotal Study Clinical Considerations