Human Subjects Protection Program

What is an IDE?

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:

What is a non-significant risk (NSR) 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.

What is a significant risk (SR) device?

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 is an IND not needed for studies involving marketed 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

What is Off-Label Use?

“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.

What is On-Label Use?

“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.

What is Drug Labeling?

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

Do studies using Investigational Drugs require an IND application?

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.  

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