IND/IDE Resources

An IND application to the FDA is required for drugs not yet FDA approved and some uses of FDA-approved drugs for a non-FDA-approved purpose or population. An IND application is a request to the FDA to authorize interstate shipping and the use of an investigational drug in a human within a clinical investigation or under the FDA’s Expanded Access Program. See 21 CFR 312.1.

An IDE application allows investigators to use an investigational device in a clinical study. An IDE application 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. See 21 CFR 812.

An individual who actually conducts a clinical investigation (i.e. under whose immediate direction the drug or test article is administered or dispensed to, or used involving, a subject). In the event an investigation is conducted by a team, the investigator is the responsible leader of the team. See 21 CFR 312.3, 21 CFR 312 Subpart D and 21 CFR 812 Subpart C.

An individual who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. See 21 CFR 312.3.

An individual who both initiates and actually conducts, alone or with others, a clinical investigation, (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject). The term does not include any person other than an individual, e.g., corporation or agency. See 21 CFR 312.3.

Note: When a researcher becomes a sponsor-investigator*, it is imperative that he/she becomes aware of the specific obligations and responsibilities in his/her role as both the investigator and sponsor of the study. See 21 CFR 312 Subpart D, 21 CFR 812 Subpart C and FDA Guidance.

Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. See 21 CFR 312.3.

Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. See 21 CFR 312.3.

Investigation means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device. See 21 CFR 812.3.

Investigational device means a device, including a transitional device, that is the object of an investigation. See 21 CFR 812.3.

Subject means a human who participates in an investigation, either as a recipient of the investigational new drug or as a control. A subject may be a healthy human or a patient with a disease. See 21 CFR 312.3.

This site is a public registry of clinical trials maintained by the National Library of Medicine at the National Institutes of Health. The ClinicalTrials.gov website is designed to provide patients, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical trials on a wide range of diseases and conditions. See Factsheet for ClinicalTrials.gov

See 21 CFR 312 Subpart D and FDA Guidance.

See 21 CFR 812 Subpart C and 21 CFR 812 Subpart E.

• See Human Research Protections Manual.

The "Sponsor" of the study is required to register and to submit results information into the ClinicalTrials.gov registry within 21 days of enrollment of the first participant and at least every 6 months for all active trials. For instructions on how to register your study in ClinicalTrials.gov go to https://www.clinicaltrials.gov/ct2/manage-recs

NOTE: Section 801 of the FDA Amendments Act of 2007 (FDAAA 801) amended the Federal Food, Drug, and Cosmetic (FD&C) Act to authorize civil monetary penalties against responsible parties who fail to comply with registration and/or results submission requirements. In addition, in relation to federally funded studies, section 402(j)(5)(A) of the Public Health Service (PHS) Act provides for the withholding of remaining or future grant funds from a grantee for failure to submit clinical trial registration and results information. See Legal Consequences.

• Guidance for Clinical Investigators, Sponsors, and IRBs Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND

• FDA - IND Application Procedures: Exemptions from IND Requirements

• FDA Investigator-Initated Investigational New Drug (IND) Applications
• New Drug Approval Application Process
• FDA Guidance Document - Investigational New Drug Applications prepared and submitted by Sponsor-Investigators (5/2015)
• FDA IND Forms and Instructions
• IND Applications for Clinical Investigations: Regulatory and Administrative Components Table

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. Additional specific responsibilities of sponsors are described elsewhere in this site. See 21 CFR 312 Subpart D.

See 21 CFR 312.110.

• FDA Portable Document Format Specifications (9/2016)
• IDE Responsibilities
• Sponsor's Responsibilities For Significant Risk Device Investigations (11/1995)
• Expanded Access for Medical Devices (Emergency Use, Compassionate Use/Individual Patient/Small Group Access, and Treatment Use)
• Device Classification
• IDE Reports
• IDE Regulations
• Frequently Asked Questions About Medical Devices
• The New 510(k) Paradigm

• FDA Submission of an IDE Application Flow Chart

• FDA Guidance Document - FDA Decisions for Investigational Device Exemption Clinical Investigations (8/2014)
• FDA Guidance Document - Factors to Consider when making benefit-risk determination for Medical Device Investigational Device Exemptions (IDEs) (1/2017)
• Information Sheet Guidance for IRBs, Clinical Investigators and Sponsors – Significant and Non-significant Risk Medical Devices (1/2006)

• FDA Device Advice: Investigational Device Exemption (IDE)

• IDE Application Process
• IDE Approval Process
• eCopy Program for Medical Device Submissions (12/2015)

Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ensuring proper monitoring of the investigation, ensuring that IRB review and approval are obtained, submitting an IDE application to FDA, and ensuring that any reviewing IRB and FDA are promptly informed of significant new information about an investigation. Additional responsibilities of sponsors are described in subparts B and G. See 21 CFR 812 Subpart C and 21 CFR 812 Subpart E.

•  See 21 CFR 812.18.

• FDA Portable Document Format Specifications (9/2016)
• IDE Responsibilities
• Sponsor's Responsibilities For Significant Risk Device Investigations (11/1995)
• Expanded Access for Medical Devices (Emergency Use, Compassionate Use/Individual Patient/Small Group Access, and Treatment Use)
• Device Classification
• IDE Reports
• IDE Regulations
• Frequently Asked Questions About Medical Devices
• The New 510(k) Paradigm

• FDA Submission of an IDE Application Flow Chart