Frequently asked questions (FAQs)
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The FDA defines a clinical investigation is an experiment in which a drug is “administered or dispensed to, or used involving, one or more human subjects. Such an experiment is any use of a drug [whether approved or unapproved] except for the use of a marketed drug in the course of medical practice." In order to conduct a clinical investigation of a drug, biologic, or device an IND or IDE application must be filed with the FDA, unless the study is exempt from IND or IDE requirements.
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The sponsor is the party who submits the application to FDA. In the absence of any other sponsor (e.g. pharmaceutical company or government agency), the investigator conducting the proposed clinical investigation is the sponsor of the IND or IDE application.
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The holder of an IND or IDE initiates and actually conducts, alone or with others, a clinical investigation, and the investigational drug or device is administered, dispensed, or used under his or her immediate direction. He or she assumes the responsibilities of both an investigator and a sponsor when all of the following are true:
- The sponsor investigator obtained an IND or IDE from FDA
- The sponsor investigator is responsible for clinical testing of the drug or device
- The sponsor investigator is conducting a clinical trial and dispensing or using the drug or device in human subjects.
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Sponsor Investigators are required to ensure regulatory compliance with FDA requirements, the protocol, IRB requirements, and all applicable regulations. IND/IDE holders must ensure that all federal, state and institutional regulations are being met.
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An Investigational New Drug (IND) application is submitted to the FDA if a drug (or biological product) not previously authorized for marketing in the US is intended to be used for the purposes of clinical investigation or, in certain cases, for the purposes of clinical treatment when no approved therapies are available.
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An IND is required when all of the following conditions exist (21CFR 312):
- The research involves a drug as that term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1)).
- The research is a clinical investigation as defined in the IND regulations (21 CFR 312.3).
- The clinical investigation is not otherwise exempt from the IND requirements in part 312 (see section IV of this guidance).
Whether an IND is needed to conduct a clinical investigation of a marketed drug primarily depends on the intent of the investigation and the degree of risk associated with the use of the drug in the investigation. A clinical investigation of a marketed drug is exempt from the IND requirements if all of the criteria for an exemption in § 312.2(b) are met:
- The drug product is lawfully marketed in the United States.
- The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication and there is no intent to use it to support any other significant change in the labeling of the drug.
- In the case of a prescription drug, the investigation is not intended to support a significant change in the advertising for the drug.
- The investigation does not involve a route of administration, dose, patient population, or other factor that significantly increases the risk (or decreases the acceptability of the risk) associated with the use of the drug product (21 CFR 312.2(b)(1)(iii)).
- The investigation is conducted in compliance with the requirements for review by an IRB (21 CFR part 56) and with the requirements for informed consent (21 CFR part 50).
- The investigation is conducted in compliance with the requirements of § 312.7 (i.e., the investigation is not intended to promote or commercialize the drug product).
Additionally, when an IND is required, the study must be conducted in compliance with 21 CFR 312.7, which deals with the promotion and sale of investigational products.
IND exempt studies must comply with informed consent and IRB approval requirements (21 CFR 50 and 56, respectively). If a study does not require an IND per the FDA, the investigator must be able to document this determination, and the Institutional Review Board (IRB) will verify documentation.
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For advice on IND or IDE submission requirements or exemptions, and for assistance in the preparation and submission of an IND or IDE, contact:
Jonna Davis, CRSO.FDAsupport@hsc.utah.edu
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An Investigational Device Exemption (IDE) application is submitted to the FDA to allow for the conduct of a clinical investigation using a significant risk device that is new or not approved for a given use.
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Significant vs. Non-significant Risk Devices
An IDE is required to study an investigational device (including new intended use of an approved device) posing significant risk (presents a potential serious risk to the health, safety, or welfare of subjects) and must be submitted to the FDA before study initiation. If the investigation involves the use of a device that does not pose significant risk to humans (a non-significant risk device), an IDE application to FDA is not required. Submissions for non-significant risk devices are made directly to the IRB. The sponsor-investigator must explain to the IRB why the device does not pose a significant risk. If the IRB agrees with the non-significant risk determination, the FDA considers the device to have an approved IDE. However, if the IRB determines that the device poses a significant risk to subjects, the sponsor-investigator must notify the FDA within five working days. Sponsor-investigators conducting non-significant risk device studies must comply with IDE requirements listed in 21 CFR 812.2(b).
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While an approved IDE allows investigators to use an investigational device for the purpose of clinical testing, not all clinical trials using devices require permission from the FDA to proceed. Device studies exempt from IDE requirements still require IRB approval (21 CFR 56). Documentation of the IDE exemption category must be submitted to IRB.
The following categories of devices are exempt from IDE requirements:
- Devices in commercial distribution before 5/28/1976
- Devices determined by FDA to be substantially equivalent to a device in commercial distribution before 5/28/1976
- Diagnostic devices that are noninvasive or do not require an invasive sampling procedure that presents significant risk, do not introduce energy into a subject or are not used as a diagnostic procedure without the confirmation of another medically established diagnostic product or procedure
- Devices used for consumer preference testing or for any test that is not intended to determine safety or effectiveness and does not expose subjects to risk
- Devices exclusively used for veterinary indications
- Devices to be shipped exclusively for research on laboratory animals
- Custom devices unless these are used to assess safety or effectiveness for commercial distribution
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