IND/IDE Support
IND/IDE Support
Helping research teams navigate the investigational new drug approval process.
Regulatory Guidance for Academic Research of Drugs and Devices
Clinical Trials for drugs being developed for initial use in humans as well as for FDA approved drugs but being investigated for additional use(s) require an Investigational New Drug Approval (IND) from the FDA prior to commencing.
For clinical trials involving marketed drug(s) for alternative use an IND Exemption (PDF) may be an acceptable alternative. The CTSI, in collaboration with the Ohio State Drug Development Institute and Nationwide Children’s Hospital’s Drug and Device Development Services, can help research teams navigate these potentially complex processes.
IND/IDE Support we provide:
- Meetings with the FDA (INTERACT, Pre-IND, Q-sub: Pre-Sub)
- IND Submission Packet Templates
- IDE Submission Packet Templates
- Expanded Access “Compassionate Use” submissions
- Clinical Hold Responses
- Guidance and training for preparing IND/IDE initial submissions, amendments/supplements, annual reports, and withdrawals/terminations
- Full preparation of IND/IDE submission packets
- Guidance with determining device risk level and classification (Note: The study sponsor maintains overall responsibility for making the final determination in collaboration with the FDA and IRB)
Request support for IND/IDE submissions and FDA meetings by contacting the CTSI-Regulatory Team
When conducting human research with an investigational drug or device (drugs or devices that have not been approved or cleared by the FDA for marketing) researchers need to obtain an exemption from the pre-marketing approval requirements in the Food Drug and Cosmetic Act, prior to starting the research. This is obtained through the Food and Drug Administration (FDA) by submitting an Investigational New Drug (IND) Application or an Investigational Device Exemption (IDE).
Once an IND is submitted to the FDA the sponsor must wait 30 days to begin the research, or until they receive a study may proceed letter. Within that 30 days the FDA may issue a clinical hold until specific items are addressed.
Once an IDE is submitted to the FDA the sponsor must wait 30 days to begin the research, or until they receive an approved or approved with conditions notification from the FDA. Within that 30 days the FDA may issue a disapproval of the research or require specific conditions be met in order to conduct the research.
IND/IDEs need to be maintained throughout the protocol lifecycle through the submission of amendments/supplements, annual reports/progress reports, safety reports and IND/IDE termination or withdrawal.
FAQs
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The Study Sponsor is responsible for obtaining the IND/IDE approval with the FDA. For Investigator-Initiated Trials (IITs), the Principal Investigator is the study sponsor and will be referred to as the Sponsor-Investigator by the FDA.
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When conducting human research with a lawfully marketed drug the research may be exempt from IND requirements if it meets the criteria in 21CFR312.2. CTSI recommends submitting an IND Exemption request to the FDA for documentation purposes, but it is not required to do so. The Institutional Review Board (IRB) of record, may require proof of IND Exemption from the FDA.
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For patients with a serious or immediately life-threatening disease or condition who have not comparable or satisfactory alternative therapy, they may be able to gain access to an investigational medical product through an expanded access program.
Expanded access is appropriate only when all of the following criteria are met:
- The patient has a serious or immediately life-threatening disease or condition
- There is no satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition
- Patient enrollment in a clinical trial is not possible
- Potential patient benefit justifies the potential risks of treatment
- Providing the investigational product will not interfere with investigational trials that could support a medical products development or marketing approval for the treatment indication.
Expanded Access may be approved for a single patient, potentially through an emergency IND, an intermediate-size patient population or through a treatment IND for widespread use.
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A medical device is any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar product including any component, part or accessory that is intended for use in the diagnosis of disease or other condition or in the cure, mitigation, treatment or prevention of disease or is intended to affect the structure or any function of the body of man or in animals or that is recognized by the National Formulary or United States Pharmacopeia.
Medical devices include items such as single use devices, implantable devices, imaging, medical equipment, software (including clinical decision support tools), diagnostic devices (including in vitro diagnostics), personal protective equipment and surgical or laboratory instruments.
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When human research is being completed with a non-significant risk (NSR) medical device, the study sponsor may conduct the research under an abbreviated IDE. This is completed by submitting supporting information to the IRB explaining why the device is NSR. If the IRB agrees with the NSR determination, FDA approval is not required since FDA approval is presumed for NSR devices.
For abbreviated IDE research protocols, FDA submissions/notifications are still required for any unanticipated adverse device effects, withdrawal of IRB approval, recall and device disposition, any failure to obtain informed consent, if the IRB determines that a device is a significant risk device, and any other information that the FDA or IRB requests.
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According to 21 CFR 812.3 a significant risk device are devices that are devices that meet at least one of the following criteria:
- Intended as an implant and poses a serious risk to the health, safety or welfare of a subject
- Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety or welfare of a subject
- Is for a use of substantial importance for diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of health and presents a potential for serious risk to the health, safety or welfare of a subject
- Otherwise presents a potential serious risk to the health, safety or welfare of a subject
Non-significant risk devices do not meet any of those criteria and may undergo research using the abbreviated IDE process.
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Some devices are exempt from IDE requirements, including devices that were commercially distributed prior to May 28, 1976; specific substantially equivalent devices, some diagnostic devices, including in vitro diagnostic devices, devices undergoing consumer preference testing that do not put a subject at risk and that is not being tested for safety and effectiveness, devices being tested in animals or for veterinary use, a custom device unless it is being used to establish safety and efficacy for commercial distribution.
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Medical devices are based on a classification system. Class I devices require general controls; Class II devices require general controls and special controls; and Class III devices require general controls and premarket approval. Class I devices are generally low risk devices, Class II are immediate risk devices, and Class III devices contain the highest risk devices. Medical devices distributed in the United States must comply with the following regulatory requirements: Establishment Registration; Medical Device Listing; Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA); Investigational Device Exemption (IDE) for studies; Quality Systems Regulation; Labeling Requirements; Medical Device Reporting (MDR).
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Research IND submissions can be submitted electronically to the FDA through the NextGen portal. To create an account through the NextGen Portal:
- Go to: CDER NextGen Portal
- Click “Sign Up”
- Fill out the corresponding information
- Add your Organization Manually
- Organization Name: The Ohio State University, [Add building address]
- DUNS: 832127323
- Add your Organization Manually
- Select “Create Account”
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IDEs can be submitted through the CDRH portal. To create an account through the CDRH Portal:
- Go to: Center for Devices and Radiological Health
- Fill out the corresponding information
- Select “Register”
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For clinical trials involving marketed drug(s) for alternative use an IND Exemption may be an acceptable alternative. The CTSI, in collaboration with the Ohio State's Drug Development Institute and Nationwide Children’s Hospital’s Drug and Device Development Services, can help research teams navigate these potentially complex processes.
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ReGARDD provides academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics and medical devices.