Human Subjects Protection Program

An investigational device exemption (IDE) is an approval that allows a medical device to be used in a clinical research study that involves human subjects or human specimens. The term “exemption” as it pertains to IDEs, means that the device is exempt from the laws that prohibit unapproved products to move in interstate commerce.

An approved IDE means that the IRB (and FDA for SR devices) has approved the sponsor’s study application and all regulatory requirements are met.

IDEs cover studies that:

• Support marking applications;
• Collect safety and/or efficacy information about a device;
• Evaluate device modifications;
• Collect device specific data about an unapproved device (even if there is no plan to submit a marketing application); or
• Support a new use of a marketed device.

Non-significant risk (NSR) devices are devices that do not pose a significant risk to the human subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and Foley catheters. An NSR device study requires only IRB approval prior to initiation of a clinical study.

The IRB is tasked with granting NSR determinations, when appropriate.

A significant risk (SR) device presents a potential for serious risk to the health, safety, or welfare of a subject. Significant risk devices may include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating or treating disease or in preventing impairment to human health. Examples include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants.

When a study is investigating a SR device, an IDE from the FDA is required. IRB review will not occur until the study has been granted an IDE from the FDA.

The FDA defines a medical device as:

• "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

A study can be deemed IND Exempt if all of the following criteria are met:

• If the study is not designed to support approval of a new indication or a change in label;
• If the study is not intended to support a significant change in the advertising for the product;
• If the study does not involve a route of administration, dosage level or patient population that significantly increases the risks (or decreases the acceptability of risk) associated with the use of the drug;
• The study is conducted in compliance with the IRB and Informed Consent regulations; and
• The study is conducted in compliance with regulations regarding promotion for investigational drugs.

An IND is not needed for studies involving marketed drugs such as:

• Some studies using commercially marketed drugs
• Some studies using in vitro diagnostic biological products (e.g., blood grouping serum, reagent red blood cells, anti-human globulin)
• Studies using drugs in vitro or in laboratory research animals

“Off-label use” is any difference in use, including indication, dose, route of administration, patient populations, and drug formulation from what is approved on the FDA label.

“On-label use” means the drug is being used in the same indication, dose, route of administration, patient populations, and drug formulation. There is no deviation from the approved FDA label. Studies involving the on-label use drug do not require an IND, as long as data will not be used in a marketing application.

Drug labeling refers to all the printed material that accompanies a drug, including the label, the wrapping, and the package insert.

Yes, an IND application is a request to the FDA for authorization to administer an investigational drug (or biologic) to human or a marketed drug in a new indication and/or patient population. However, there are IND Exemptions. Please refer to the section on IND Exemptions for more information.